NCT03822871 is a Phase 1 clinical trial of CTT1403 in Prostate Cancer, sponsored by Cancer Targeted Technology.

Who is sponsoring NCT03822871?

NCT03822871 is sponsored by Cancer Targeted Technology.

What drugs are being tested in NCT03822871?

Interventions in NCT03822871: CTT1403, CTT1057, 68Ga-PSMA-11.

What condition does NCT03822871 study?

NCT03822871 studies Prostate Cancer.

Is NCT03822871 still recruiting?

NCT03822871 is currently completed. Last updated 21 March 2024.

Are results published for NCT03822871?

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

Last reviewed 2024-03-21 · How we verify

NCT03822871

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

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

Completed Phase 1 Results posted Last updated 21 March 2024

What this trial tests

Phase 1 trial testing CTT1403 in Prostate Cancer in 17 participants. Completed in 8 February 2023.

Timeline

1 April 2019

Primary endpoint
28 October 2022

8 February 2023

Quick facts

Lead sponsor	Cancer Targeted Technology
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	1 April 2019
Primary completion	28 October 2022
Estimated completion	8 February 2023
Sites	1 location across United States

Drugs / interventions tested

CTT1403 — full drug profile →
CTT1057 — full drug profile →
68Ga-PSMA-11 — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Cancer Targeted Technology — full company profile →

Who can join

18 and older, male only, with Prostate 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.

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 Primary · 6-8 weeks from time of injection on Cycle 1 - Day 1

The dose-limiting toxicity was defined as any of the following: 1. Grade 4 neutropenia lasting \> 5 consecutive days 2. Grade 3 or 4 febrile neutropenia 3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion 4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management 5. Any

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	0
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0
0.75 GBq Cohort	1
1.5 GBq Cohort	1
2.0 GBq Cohort	1
3.0 GBq Cohort	3
4.5 GBq Cohort	4
6.0 GBq Cohort	3
7.5 GBq Cohort	3
9.0 GBq Cohort	1

Objective Response Rate by RECIST v1.1 Criteria Primary · Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days.

Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.

Number of patients with stable disease on Cycle 1-Day 35

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	1
2.0 GBq Cohort	0
3.0 GBq Cohort	1
4.5 GBq Cohort	4
6.0 GBq Cohort	2
7.5 GBq Cohort	1
9.0 GBq Cohort	1

Number of patients with progressive disease on Cycle 1-Day 35

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	1
3.0 GBq Cohort	2
4.5 GBq Cohort	0
6.0 GBq Cohort	1
7.5 GBq Cohort	1
9.0 GBq Cohort	0

Number of patients with stable disease on Cycle 2-Day 35

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	1
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	2
6.0 GBq Cohort	1
7.5 GBq Cohort	3
9.0 GBq Cohort	0

Number of patients with progressive disease on Cycle 2-Day 35

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	1
4.5 GBq Cohort	0
6.0 GBq Cohort	1
7.5 GBq Cohort	0
9.0 GBq Cohort	1

Number of patients with stable disease 30 days after last dose

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	0
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0

Number of patients with progressive disease 30 days after last dose

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	1
3.0 GBq Cohort	1
4.5 GBq Cohort	0
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0

Number of patients with stable disease 8 weeks post-treatment

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	0
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0

Number of patients with progressive disease 8 weeks post-treatment

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	1
6.0 GBq Cohort	1
7.5 GBq Cohort	1
9.0 GBq Cohort	0

Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging Secondary · 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1

Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.

Mean absorbed dose per GBq - Left Kidney

Group	Value	95% CI
0.75 GBq Cohort	0.608
1.5 GBq Cohort	0.611
2.0 GBq Cohort	0.760
3.0 GBq Cohort	1.024	± 0.428
4.5 GBq Cohort	0.579	± 0.127
6.0 GBq Cohort	0.518	± 0.072
7.5 GBq Cohort	0.774	± 0.199
9.0 GBq Cohort	0.699

Mean absorbed dose per GBq - Right Kidney

Group	Value	95% CI
0.75 GBq Cohort	0593
1.5 GBq Cohort	0.585
2.0 GBq Cohort	1.021
3.0 GBq Cohort	1.032	± 0.550
4.5 GBq Cohort	0.638	± 0.108
6.0 GBq Cohort	0.477	± 0.064
7.5 GBq Cohort	0.731	± 0.279
9.0 GBq Cohort	0.677

Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index Secondary · Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days.

The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.

Change in rating of pain at its worst in the past 24 hours from Cycle 1-Day 1 to Cycle 2-Day 1

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	1
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	1
4.5 GBq Cohort	1
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	1
6.0 GBq Cohort	1
7.5 GBq Cohort	2
9.0 GBq Cohort	0

Change in rating of average pain from Cycle 1-Day 1 to Cycle 2-Day 1

Group	Value	95% CI
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	0
6.0 GBq Cohort	1
7.5 GBq Cohort	0
9.0 GBq Cohort	0
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	1
4.5 GBq Cohort	0
6.0 GBq Cohort	0
7.5 GBq Cohort	0
9.0 GBq Cohort	0
0.75 GBq Cohort	0
1.5 GBq Cohort	0
2.0 GBq Cohort	0
3.0 GBq Cohort	0
4.5 GBq Cohort	3
6.0 GBq Cohort	0
7.5 GBq Cohort	2
9.0 GBq Cohort	0

Assessment of Pharmacokinetics of CTT1403 Secondary · Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs)

The distribution half-life and the elimination half-life of CTT1403 were calculated.

Distribution half-life

Group	Value	95% CI
1.5 GBq Cohort	0.747
2.0 GBq Cohort	1.044
3.0 GBq Cohort	0.699	± 0.267
4.5 GBq Cohort	0.813	± 0.068
6.0 GBq Cohort	0.680	± 0.149

Elimination half-life

Group	Value	95% CI
1.5 GBq Cohort	28.881
2.0 GBq Cohort	23.902
3.0 GBq Cohort	29.616	± 2.673
4.5 GBq Cohort	36.867	± 4.531
6.0 GBq Cohort	38.173	± 11.365

Adverse events — posted to ClinicalTrials.gov

Time frame: Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0.75 GBq Cohort

Serious: 0/1 (0%)

Deaths: 1/1

1.5 GBq Cohort

Serious: 0/1 (0%)

Deaths: 1/1

2.0 GBq Cohort

Serious: 0/1 (0%)

Deaths: 1/1

3.0 GBq Cohort

Serious: 0/3 (0%)

Deaths: 3/3

4.5 GBq Cohort

Serious: 1/4 (25%)

Deaths: 4/4

6.0 GBq Cohort

Serious: 1/3 (33%)

Deaths: 3/3

7.5 GBq Cohort

Serious: 1/3 (33%)

Deaths: 3/3

9.0 GBq Cohort

Serious: 0/1 (0%)

Deaths: 1/1

Serious adverse events (6 terms)

Reaction	System	0.75 GBq Cohort	1.5 GBq Cohort	2.0 GBq Cohort	3.0 GBq Cohort	4.5 GBq Cohort	6.0 GBq Cohort	7.5 GBq Cohort	9.0 GBq Cohort
Grade 3 Fall	General disorders	—	—	—	—	—	—	—	—
Grade 3 Syncope	General disorders	—	—	—	—	—	—	—	—
Grade 3 Atrial Fibrillation with Rapid Ventricular Response	Cardiac disorders	—	—	—	—	—	—	—	—
Grade 3 Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Grade 3 Hyponatremia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Grade 3 Cerebrovascular Accident	Nervous system disorders	—	—	—	—	—	—	—	—

Other adverse events (21 terms — click to expand)

Reaction	System	0.75 GBq Cohort	1.5 GBq Cohort	2.0 GBq Cohort	3.0 GBq Cohort	4.5 GBq Cohort	6.0 GBq Cohort	7.5 GBq Cohort	9.0 GBq Cohort
Decreased apetite	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dry heave	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal malaise	General disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Bone Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Blood in urine	Renal and urinary disorders	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Vomitting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diaphoresis	General disorders	—	—	—	—	—	—	—	—
Taste changes	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Periorbital swelling	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Intermittent bloating	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Grade 3 Fall, Grade 3 Syncope, Grade 3 Atrial Fibrillation with Rapid Ventricular Response, Grade 3 Pulmonary Edema, Grade 3 Hyponatremia, Grade 3 Cerebrovascular Accident.

Data from ClinicalTrials.gov NCT03822871 adverse events section.

Sponsor's own description

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

Publications & conference data

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

Radiopharmaceutical therapy in cancer: clinical advances and challenges.
Sgouros G, Bodei L, McDevitt MR, Nedrow JR. · · 2020 · cited 551× · PMID 32728208 · DOI 10.1038/s41573-020-0073-9
Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.
Ramnaraign B, Sartor O. · · 2023 · cited 49× · PMID 36806966 · DOI 10.1093/oncolo/oyac279
Towards the Magic Radioactive Bullet: Improving Targeted Radionuclide Therapy by Reducing the Renal Retention of Radioligands.
de Roode KE, Joosten L, Behe M. · · 2024 · cited 33× · PMID 38399470 · DOI 10.3390/ph17020256
Preclinical Dosimetry, Imaging, and Targeted Radionuclide Therapy Studies of Lu-177-Labeled Albumin-Binding, PSMA-Targeted CTT1403.
Ling X, Latoche JD, Choy CJ, Kurland BF, et al · · 2020 · cited 28× · PMID 31321650 · DOI 10.1007/s11307-019-01404-8
More Than Meets the Eye: Scientific Rationale behind Molecular Imaging and Therapeutic Targeting of Prostate-Specific Membrane Antigen (PSMA) in Metastatic Prostate Cancer and Beyond.
Hyväkkä A, Virtanen V, Kemppainen J, Grönroos TJ, et al · · 2021 · cited 22× · PMID 34067046 · DOI 10.3390/cancers13092244
Combination Therapy, a Promising Approach to Enhance the Efficacy of Radionuclide and Targeted Radionuclide Therapy of Prostate and Breast Cancer.
Damiana TST, Dalm SU. · · 2021 · cited 16× · PMID 34067215 · DOI 10.3390/pharmaceutics13050674
PSMA theragnostics for metastatic castration resistant prostate cancer.
Song H, Guja KE, Iagaru A. · · 2022 · cited 8× · PMID 35659674 · DOI 10.1016/j.tranon.2022.101438

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Other Cancer Targeted Technology trials

Trials by the same sponsor.

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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 NCT03822871 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Cancer Targeted Technology
Last refreshed: 21 March 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/NCT03822871.

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

NCT03822871

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 (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Prostate Cancer

Other Cancer Targeted Technology trials

Verify against primary sources