NCT03514121 (FPA150-001) is a EARLY_PHASE1 clinical trial of FPA150 in Breast Cancer, sponsored by Five Prime Therapeutics, Inc..

Who is sponsoring NCT03514121?

NCT03514121 is sponsored by Five Prime Therapeutics, Inc..

What drugs are being tested in NCT03514121?

Interventions in NCT03514121: FPA150, Pembrolizumab.

Is NCT03514121 still recruiting?

NCT03514121 is currently terminated. Last updated 22 November 2024.

Are results published for NCT03514121?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-22 · How we verify

NCT03514121: FPA150-001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FPA150 in Patients With Advanced Solid Tumors

Terminated EARLY_PHASE1 Results posted Last updated 22 November 2024

What this trial tests

EARLY_PHASE1 trial testing FPA150 in Breast Cancer in 95 participants. Terminated before completion.

Timeline

27 March 2018

Primary endpoint
21 April 2021

21 April 2021

Quick facts

Lead sponsor	Five Prime Therapeutics, Inc.
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	27 March 2018
Primary completion	21 April 2021
Estimated completion	21 April 2021
Sites	18 locations across United States, South Korea

Drugs / interventions tested

FPA150 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Ovarian Cancer — all drugs for Ovarian Cancer →
Endometrial Cancer — all drugs for Endometrial Cancer →
Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Five Prime Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 99, any sex, with Breast Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1a Monotherapy: Number of Participants Experiencing Grade 3 and Grade 4 Adverse Events (AEs) Primary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. Grade 3 and 4 severity ratings were defined as follows: Grade 3: Severe or medically significant but non-immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE Grade 4: Life-threatening consequences; urgent intervention indicated

Group	Value	95% CI
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	4
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	5
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	1

Phase 1a Monotherapy: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) Primary · Up to 21 days

DLTs were defined as any of the following events regardless of attribution (except for those events clearly due to the underlying disease or extraneous causes): Any Grade 3 or higher non-hematologic toxicity (except Grade 3 nausea, vomiting, and diarrhea) that occurred within the first 21 days of treatment. Grade 3 nausea, vomiting, diarrhea lasting \>72 hours, that occurred within the first 21 days of treatment. Febrile neutropenia and/or documented infection, Grade 4 neutropenia that lasted more than 7 days, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia accompanied by bleeding wit

Group	Value	95% CI
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	0

Phase 1a Monotherapy: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Primary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)

TEAEs were defined as an AE that began or worsened in severity after at least one dose of study treatment (FPA150) had been administered. Clinically significant laboratory abnormalities and ECG abnormalities are included as TEAEs.

Group	Value	95% CI
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	3
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	7
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	7
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	4

Phase 1b Monotherapy: Number of Participants Experiencing AEs Primary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect or important medical events. Clinically significant laboratory abnormalities and ECG abnormalities were

Breast Cancer

Group	Value	95% CI
Phase 1b Monotherapy	18

Ovarian Cancer

Group	Value	95% CI
Phase 1b Monotherapy	16

Endometrial Cancer

Group	Value	95% CI
Phase 1b Monotherapy	16

Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing AEs Primary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgme

Group	Value	95% CI
Phase 1a Combination Safety Lead-In & Phase 1b Combination	11

Phase 1a Combination Safety Lead-In & Phase 1b Combination: Number of Participants Experiencing Grade 3 and Grade 4 AEs Primary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 12.00 [6.00, 36.43] weeks)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgme

Group	Value	95% CI
Phase 1a Combination Safety Lead-In & Phase 1b Combination	4

Phase 1a Monotherapy: Number of Participants With ADAs to FPA150 Secondary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 9.143 [3.00, 52.00] weeks)

All ADA samples were collected prior to dosing. A baseline ADA-positive patient was defined as a patient who had an ADA positive sample at baseline. Postbaseline treatment induced ADA positive is derived as participants with ADA negative at baseline and ADA positive at any postbaseline timepoint, or ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.

Baseline

Group	Value	95% CI
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	2
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	3
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	4
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	4
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	0

Postbaseline

Group	Value	95% CI
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	2
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	4
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	3
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B	0
Phase 1a Monotherapy Dose Escalation + Exploration Dose C	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E	1
Phase 1a Monotherapy Dose Escalation + Exploration Dose F	0
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G	1
Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H	0

Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 at Baseline Secondary · Cycle 1 day 1 pre-dose (baseline)

Breast Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Ovarian Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Endometrial Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Phase 1b Monotherapy: Number of Participants With ADAs to FPA150 Postbaseline Secondary · From day 1 up to 28 days after last dose (median [min, max] treatment duration= 6.35 [3.00, 108.14] weeks)

Breast Cancer

Group	Value	95% CI
Phase 1b Monotherapy	0

Ovarian Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Endometrial Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Phase 1b Monotherapy: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Secondary · Up to approximately 24 months

ORR was defined as the percentage of participants who achieved best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. The BOR was the best response documented from first dose until the end of study, first disease progression, death, or start of new anti-cancer therapy, whichever was earlier.

Breast Cancer

Group	Value	95% CI
Phase 1b Monotherapy	0

Ovarian Cancer

Group	Value	95% CI
Phase 1b Monotherapy	1

Endometrial Cancer

Group	Value	95% CI
Phase 1b Monotherapy	0

Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1 Secondary · Up to approximately 24 months

DOR is defined as the time from first onset of response (CR or PR determined by the investigator per RECIST v1.1) that is subsequently confirmed until the onset of progressive disease or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response. DOR was estimated using the Kaplan-Meier method.

Group	Value	95% CI
Phase 1b Monotherapy	NA	NA – NA

Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 Secondary · Up to approximately 24 months

PFS defined as time from the first dose of study treatment until the first documentation by the investigator of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Patients who were alive and progression-free at the time of data analysis were censored at the time of their last assessment for tumor response.

Group	Value	95% CI
Phase 1b Monotherapy	1.40	0.79 – 5.42

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected through 28 days after last dose of study drug. Median (min, max) duration of exposure was 9.14 [3.0, 52.0] weeks for the Phase 1a Dose Escalation + Explorations part of the study, 6.36 [3.0, 108.1] weeks for the Phase 1b Monotherapy part and 12.00 [6.0, 36.4] weeks for the Phase 1a combination lead-in and Phase 1b combination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose A

Serious: 1/1 (100%)

Deaths: 0/1

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose B

Serious: 0/1 (0%)

Deaths: 0/1

Phase 1a Monotherapy Dose Escalation + Exploration Dose C

Serious: 0/3 (0%)

Deaths: 0/3

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose D

Serious: 0/1 (0%)

Deaths: 0/1

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose E

Serious: 1/3 (33%)

Deaths: 0/3

Phase 1a Monotherapy Dose Escalation + Exploration Dose F

Serious: 1/8 (13%)

Deaths: 3/8

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose G

Serious: 3/8 (38%)

Deaths: 2/8

Phase 1a Monotherapy Dose Escalation + Exploration FPA150 Dose H

Serious: 0/4 (0%)

Deaths: 1/4

Phase 1b Monotherapy FPA150 Dose H (Breast)

Serious: 3/21 (14%)

Deaths: 9/21

Phase 1b Monotherapy FPA150 Dose H (Ovarian)

Serious: 6/17 (35%)

Deaths: 10/17

Phase 1b Monotherapy FPA150 Dose H (Endometrial)

Serious: 5/16 (31%)

Deaths: 7/16

Phase 1a Combination Safety Lead-In & Phase 1b Combination FPA150 Dose H & Pembrolizumab 200 mg

Serious: 3/12 (25%)

Deaths: 3/12

Serious adverse events (26 terms)

Reaction	System	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1b Monotherapy FPA15…	Phase 1b Monotherapy FPA15…	Phase 1b Monotherapy FPA15…	Phase 1a Combination Safet…
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Obstruction gastric	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal varices haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Enterobacter bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypernatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hydronephrosis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract obstruction	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (148 terms — click to expand)

Reaction	System	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1a Monotherapy Dose …	Phase 1b Monotherapy FPA15…	Phase 1b Monotherapy FPA15…	Phase 1b Monotherapy FPA15…	Phase 1a Combination Safet…
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Memory impairment	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pelvic pain	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Small intestinal obstruction, Cardiac arrest, Abdominal pain, Colitis, Gastrooesophageal reflux disease, Haematemesis, Nausea, Obstruction gastric.

Data from ClinicalTrials.gov NCT03514121 adverse events section.

Sponsor's own description

This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Immunotherapy in Non-Small Cell Lung Cancer: Facts and Hopes.
Doroshow DB, Sanmamed MF, Hastings K, Politi K, et al · · 2019 · cited 526× · PMID 30824587 · DOI 10.1158/1078-0432.ccr-18-1538
Next generation of immune checkpoint inhibitors and beyond.
Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
If we build it they will come: targeting the immune response to breast cancer.
Gatti-Mays ME, Balko JM, Gameiro SR, Bear HD, et al · · 2019 · cited 152× · PMID 31700993 · DOI 10.1038/s41523-019-0133-7
Immunotherapy in endometrial cancer: rationale, practice and perspectives.
Cao W, Ma X, Fischer JV, Sun C, et al · · 2021 · cited 79× · PMID 34134781 · DOI 10.1186/s40364-021-00301-z
Immunotherapy in Ovarian Cancer: Thinking Beyond PD-1/PD-L1.
Chardin L, Leary A. · · 2021 · cited 72× · PMID 34966689 · DOI 10.3389/fonc.2021.795547
High expression of B7-H3 on stromal cells defines tumor and stromal compartments in epithelial ovarian cancer and is associated with limited immune activation.
MacGregor HL, Sayad A, Elia A, Wang BX, et al · · 2019 · cited 59× · PMID 31892360 · DOI 10.1186/s40425-019-0816-5
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z

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NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Five Prime Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04074759 — FPT155 in Patients With Advanced Solid Tumors · Phase 1 · terminated
NCT03694522 — A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer · Phase 2 · completed
NCT03343301 — A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer · Phase 1 · completed
NCT02526017 — Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers · Phase 1 · completed
NCT03801278 — An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03514121 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Five Prime Therapeutics, Inc.
Last refreshed: 22 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03514121.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03514121: FPA150-001

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (26 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Breast Cancer

Other Five Prime Therapeutics, Inc. trials

Verify against primary sources