A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer

January 8, 2024 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer

This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 2
  • 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:

  1. Voluntary participation and written informed consent.
  2. Be able to provide fresh or archived tumour tissue.
  3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  4. At least one measurable lesion according to RECIST v1.1.
  5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  6. With a life expectancy ≥ 12 weeks.
  7. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

  1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
  2. Previous or co-existing malignancies.
  3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
  4. Subjects with active hepatitis B or active hepatitis C;
  5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
  6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
  7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.

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: Treatment group 1: SHR-1921
Drug: SHR-1921
SHR-1921
Experimental: Treatment group 2: SHR-1921 + carboplatin dose level 1
Drug: carboplatin
carboplatin AUC 4
Drug: carboplatin
carboplatin AUC 5
Experimental: Treatment group 3: SHR-1921 + carboplatin dose level 2
Drug: carboplatin
carboplatin AUC 4
Drug: carboplatin
carboplatin AUC 5
Other: Treatment group 4: platinum-based doublet chemotherapy
Drug: platinum-based doublet chemotherapy
platinum-based doublet chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate Assessed by Investigator According to RECIST v1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Suzhou Suncadia 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)

February 15, 2024

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1921-301

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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