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

NCT06211023 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-A1921-301
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate Assessed by Investigator According to RECIST v1.1

  Screening up to study completion, an average of 1 year

Secondary Outcomes (5)

• Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Overall Survival (OS)

  Screening up to study completion, an average of 1 year

• CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria

  Screening up to study completion, an average of 1 year

Study Arms (4)

Treatment group 1: SHR-1921

EXPERIMENTAL

Drug: SHR-1921

Treatment group 2: SHR-1921 + carboplatin dose level 1

EXPERIMENTAL

Drug: carboplatin

Treatment group 3: SHR-1921 + carboplatin dose level 2

EXPERIMENTAL

Drug: carboplatin

Treatment group 4: platinum-based doublet chemotherapy

OTHER

Drug: platinum-based doublet chemotherapy

Interventions

SHR-1921 DRUG

SHR-1921

Treatment group 1: SHR-1921

carboplatin DRUG

carboplatin AUC 4

Treatment group 2: SHR-1921 + carboplatin dose level 1

platinum-based doublet chemotherapy DRUG

platinum-based doublet chemotherapy

Treatment group 4: platinum-based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yuanchao Wang

CONTACT

0518-81220278; yuanchao.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01