JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancers
• Intervention / Treatment: Drug: Paclitaxel; Drug: JSKN003; Drug: Doxorubicin; Drug: Topotecan

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lingying Wu, Doctor; Phone Number: 8610-87788495; Email: wulingying@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: JSKN003-306
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms; Antibiotics, Antineoplastic; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Doxorubicin; Paclitaxel; Topotecan
• Other Study ID Numbers: JSKN003-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No