NCT05613088

A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Completed Phase 2 Results posted Last updated 20 October 2025

What this trial tests

Phase 2 trial testing MORAb-202 in Neoplasms, Ovarian in 106 participants. Completed in 11 September 2025.

Timeline

1 February 2023

Primary endpoint
17 June 2024

11 September 2025

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	1 February 2023
Primary completion	17 June 2024
Estimated completion	11 September 2025
Sites	50 locations across Italy, Japan, Belgium, Chile, Israel, South Korea, Australia, United States

Drugs / interventions tested

• MORAb-202
• Paclitaxel — full drug profile →
• Pegylated Liposomal Doxorubicin (PLD) (pegylated-liposomal-doxorubicin-pld) — full drug profile →
• Topotecan (topotecan) — full drug profile →

Conditions studied

• Neoplasms, Ovarian — all drugs for Neoplasms, Ovarian →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, female only, with Neoplasms, Ovarian. 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.

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment Primary · From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)

Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of tar

Group	Value	95% CI
MORAb-202	20.0	11.4 – 31.3
Investigator's Choice (IC) Chemotherapy	13.9	4.7 – 29.5

Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose Primary · From first dose of study medication up to 6 months

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

Group	Value	95% CI
MORAb-202	2
Investigator's Choice (IC) Chemotherapy	0

Number of Participants With Adverse Events (AEs) Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

Group	Value	95% CI
MORAb-202	67
Investigator's Choice (IC) Chemotherapy	32

Number of Participants With Serious Adverse Events (SAEs) Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Group	Value	95% CI
MORAb-202	19
Investigator's Choice (IC) Chemotherapy	10

Number of Participants With AEs Leading to Discontinuation Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

Group	Value	95% CI
MORAb-202	3
Investigator's Choice (IC) Chemotherapy	0

Number of Participants With Treatment-Related AEs Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

Group	Value	95% CI
MORAb-202	53
Investigator's Choice (IC) Chemotherapy	29

Number of Participants With Treatment-Related SAEs Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Group	Value	95% CI
MORAb-202	1
Investigator's Choice (IC) Chemotherapy	2

Number of Participants With AEs of Special Interest (AESIs) Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis

Infusion-related reactions

Group	Value	95% CI
MORAb-202	1
Investigator's Choice (IC) Chemotherapy	1

Interstitial lung disease (ILD)

Group	Value	95% CI
MORAb-202	2
Investigator's Choice (IC) Chemotherapy	0

Pneumonitis

Group	Value	95% CI
MORAb-202	13
Investigator's Choice (IC) Chemotherapy	0

Number of Participants Who Died Secondary · From first dose of study medication until death due to any cause (up to 70 weeks)

Number of participants who died during the study.

Group	Value	95% CI
MORAb-202	21
Investigator's Choice (IC) Chemotherapy	6

Number of Participants With Grade 3-4 Laboratory Abnormalities Secondary · From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Grade 3: Lymphocytes (absolute)

Group	Value	95% CI
MORAb-202	3
Investigator's Choice (IC) Chemotherapy	0

Grade 3: Absolute neutrophil count

Group	Value	95% CI
MORAb-202	3
Investigator's Choice (IC) Chemotherapy	9

Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment Secondary · From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)

Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At lea

Group	Value	95% CI
MORAb-202	80.0	68.7 – 88.6
Investigator's Choice (IC) Chemotherapy	69.4	51.9 – 83.7

Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment Secondary · From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)

Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20%

Group	Value	95% CI
MORAb-202	4.42	2.50 – NA
Investigator's Choice (IC) Chemotherapy	5.55	2.37 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MORAb-202

Serious: 22/70 (31%)

Deaths: 34/70

Investigator's Choice (IC) Chemotherapy

Serious: 11/34 (32%)

Deaths: 18/36

Serious adverse events (28 terms)

Reaction	System	MORAb-202	Investigator's Choice (IC)…
Intestinal obstruction	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Intestinal pseudo-obstruction	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Agranulocytosis	Blood and lymphatic system disorders	—	—
Coronary artery occlusion	Cardiac disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Duodenal obstruction	Gastrointestinal disorders	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Pain	General disorders	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—
Abdominal abscess	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Renal abscess	Infections and infestations	—	—
Head injury	Injury, poisoning and procedural complications	—	—
Neutrophil count decreased	Investigations	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—

Other adverse events (56 terms — click to expand)

Reaction	System	MORAb-202	Investigator's Choice (IC)…
Constipation	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Asthenia	General disorders	—	—
Fatigue	General disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Neutrophil count decreased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Neuropathy peripheral	Nervous system disorders	—	—
Oedema peripheral	General disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Mucosal inflammation	General disorders	—	—
Pyrexia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Blood magnesium decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Weight decreased	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Intestinal obstruction, Abdominal pain, Small intestinal obstruction, Ileus, Intestinal pseudo-obstruction, Pyrexia, Malignant neoplasm progression, Agranulocytosis.

Data from ClinicalTrials.gov NCT05613088 adverse events section.

Sponsor's own description

The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

Publications & conference data

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

1. Resistance to antibody-drug conjugates: A review.
   Li S, Zhao X, Fu K, Zhu S, et al · · 2025 · cited 32× · PMID 40177568 · DOI 10.1016/j.apsb.2024.12.036
2. Advancements in antibody-drug conjugates as cancer therapeutics.
   Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
3. Antibody-drug conjugates as targeted therapy for treating gynecologic cancers: update 2025.
   Silverstein J, Karlan B, Herrington N, Konecny G. · · 2025 · cited 11× · PMID 39480912 · DOI 10.1097/gco.0000000000001002
4. Antibody-Drug Conjugates: The New Treatment Approaches for Ovarian Cancer.
   Sato S, Shoji T, Jo A, Otsuka H, et al · · 2024 · cited 10× · PMID 39061184 · DOI 10.3390/cancers16142545
5. Folate Receptor Alpha-A Secret Weapon in Ovarian Cancer Treatment?
   Bukowski K, Rogalska A, Marczak A. · · 2024 · cited 8× · PMID 39595996 · DOI 10.3390/ijms252211927
6. Unveiling the Immunogenicity of Ovarian Tumors as the Crucial Catalyst for Therapeutic Success.
   Rodriguez GM, Yakubovich E, Vanderhyden BC. · · 2023 · cited 8× · PMID 38067396 · DOI 10.3390/cancers15235694
7. Value of Antibody Drug Conjugates for Gynecological Cancers: A Modern Appraisal Following Recent FDA Approvals.
   McNamara B, Chang Y, Goreshnik A, Santin AD. · · 2023 · cited 8× · PMID 37663226 · DOI 10.2147/ijwh.s400537
8. Natural Products Derived from Marine Sponges with Antitumor Potential against Lung Cancer: A Systematic Review.
   Ortigosa-Palomo A, Quiñonero F, Ortiz R, Sarabia F, et al · · 2024 · cited 7× · PMID 38535442 · DOI 10.3390/md22030101