SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

NCT06394492 | Recruiting Phase 3

• 1 other identifier: SHR-A1921-303
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1

  Screening up to study completion, an average of 1 year

Secondary Outcomes (7)

• Overall Survival (OS)

  Screening up to study completion, an average of 1 year

• Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Duration of Response (DoR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria

  Screening up to study completion, an average of 1 year

Study Arms (2)

Treatment group 1: SHR-A1921

EXPERIMENTAL

Drug: SHR-A1921

Treatment group 2: Investigator's choice of chemotherapy

ACTIVE COMPARATOR

Drug: Doxorubicin; Drug: Paclitaxel; Drug: Topotecan

Interventions

SHR-A1921 DRUG

SHR-A1921 dose 1

Treatment group 1: SHR-A1921

Doxorubicin DRUG

Doxorubicin dose 2

Treatment group 2: Investigator's choice of chemotherapy

Paclitaxel DRUG

Paclitaxel dose 3

Treatment group 2: Investigator's choice of chemotherapy

Topotecan DRUG

Topotecan dose 4

Treatment group 2: Investigator's choice of 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.
• years and older, female.
• Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Patients must have platinum-resistant disease
• Be able to provide fresh or archived tumour tissue.
• 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.
• Contraception is required during the trial.

You may not qualify if:

• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
• Previous or co-existing malignancies.
• Current or History of ILD.
• Clinical symptoms or diseases of the heart that are not well controlled.
• Arterial/venous thrombosis events occurred before the first dose.
• Grade ≥2 bleeding events of CTCAE occurred before the first dose.
• Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
• Patients with intestinal obstruction or parenteral nutrition before the first dose.
• Serious infection before the first dose.
• Active hepatitis B or active hepatitis C.
• Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
• Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
• Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
• Other inappropriate situation considered by the investigator.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Doxorubicin; Paclitaxel; Topotecan

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)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Shuni Wang

CONTACT

+86 021-61053363; shuni.wang@hengrui.com

Di Zong

CONTACT

+86 021-61053363; di.zong@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (2)