JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

December 27, 2024 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to approximately 22 months
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)
Time Frame: 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
Up to approximately 22 months
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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
Time Frame: Up to approximately 22 months
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)
Time Frame: 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.
Up to approximately 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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