JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

Phase 3

Not yet recruiting

• Conditions: Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancers
• Interventions: Drug: JSKN003; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Topotecan

• Registration Number: NCT06751485
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief Summary

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-27
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-15
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 430

Inclusion Criteria

• Voluntary participation and written informed consent.
• ≥18 years;
• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Confirmed platinum-resistant relapse.
• According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.
• Expected survival of more than 3 months.
• ECOG performance status score of 0 or 1.
• Adequate organ function.
• Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.

Exclusion Criteria

• Primary platinum-refractory disease.
• Active central nervous system metastases.
• Uncontrolled pleural effusion.
• Previous treatment with topoisomerase I inhibitor ADCs.
• Other malignant tumors within 5 years.
• Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease.
• Uncontrolled comorbidities.
• Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
• History of allogeneic bone marrow or organ transplantation.
• Allergic reactions or hypersensitivity to antibody drugs.
• Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Treatment group 1:JSKN003	JSKN003	Drug: JSKN003 JSKN003 dose 1
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy	Doxorubicin	Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy	Paclitaxel	Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy	Topotecan	Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1	Up to approximately 22 months	PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1	Up to approximately 22 months	DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Overall Survival (OS)	Up to approximately 22 months	OS was defined as the time from the date of first dose until the date of death from any cause
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1	Up to approximately 22 months	ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1	Up to approximately 22 months	DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
PFS evaluated by the Investigator as per RECIST 1.1	Up to approximately 22 months	PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
ORR evaluated by the Investigator as per RECIST 1.1	Up to approximately 22 months	ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
DoR evaluated by the Investigator as per RECIST 1.1	Up to approximately 22 months	DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
DCR evaluated by the Investigator as per RECIST 1.1	Up to approximately 22 months	DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria	Up to approximately 22 months	CA-125 Response Rate was assessed according to the GCIG criteria
Number and Severity of Treatment-emergent Adverse Events (TEAEs)	Up to approximately 22 months	The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.