A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer

An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer

The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cervical Cancer; Recurrent Cervical Cancer
• Intervention / Treatment: Drug: Gemcitabine Hydrochloride for Injection; Drug: SHR-A2102 for Injection; Drug: Pemetrexed Disodium for Injection; Drug: Topotecan Hydrochloride for Injection; Drug: Paclitaxel for Injection (Albumin bound)

• Study Type: Interventional
• Enrollment (Estimated): 398
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhifei Lin; Phone Number: +86-0518-82342973; Email: zhifei.lin.zl3@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Principal Investigator: Jihong Liu
      • Contact: Jihong Liu; Phone Number: +86-020-87341614; Email: LIUJH@SYSUCC.ORG.CN

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
3. Provide primary or metastatic tumor samples.
4. At least one measurable lesion (RECIST version 1.1).
5. ECOG 0~ 1.
6. With adequate organ functions.
7. Expected overall survival is ≥12 weeks.

Exclusion Criteria:

1. With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
2. With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
3. With a history of or concurrent other malignant tumor(s).
4. Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
5. With known or suspected interstitial lung disease.
6. With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
7. With poorly controlled cardiac clinical symptoms or diseases.
8. Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
9. With severe infections occurring within 1 month prior to randomization.
10. With active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] test and hepatitis B virus [HBV] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] test and detectable hepatitis C virus [HCV] RNA at screening).
11. With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment.
12. With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
13. Have received systemic anti-tumor therapy within 28 days prior to randomization.
14. With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures.
15. Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for the study.

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: SHR-A2102 Group; Participants receive SHR-A2102 for injection.	Drug: SHR-A2102 for Injection; SHR-A2102 for injection.
Active Comparator: The investigator's choice of chemotherapy Group; Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).	Drug: Gemcitabine Hydrochloride for Injection; Gemcitabine Hydrochloride for injection.; Drug: Pemetrexed Disodium for Injection; Pemetrexed Disodium for injection.; Drug: Topotecan Hydrochloride for Injection; Topotecan Hydrochloride for injection.; Drug: Paclitaxel for Injection (Albumin bound); Paclitaxel for injection (Albumin bound).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.	Up to 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Assessed by the investigator according to RECIST 1.1 criteria.	Up to 3 years.
Objective Response Rate (ORR)	Assessed by the investigator according to RECIST 1.1 criteria.	Up to 3 years.
Duration of response (DoR)	Assessed by the investigator according to RECIST 1.1 criteria.	Up to 3 years.
Disease control rate (DCR)	Assessed by the investigator according to RECIST 1.1 criteria.	Up to 3 years.
Adverse Events (AEs)	Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.	Up to 3 years.
Serious Adverse Events (AEs)	Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.	Up to 3 years.
Plasma concentrations of SHR-A2102	Pharmacokinetics (PK) traits of SHR-A2102.	Up to 3 years.
Plasma concentrations of SHR-A2102 metabolites	Pharmacokinetics (PK) traits of SHR-A2102.	Up to 3 years.
Incidence of Anti-Drug Antibody (ADA) of SHR-A2102		Up to 3 years.
Incidence of Neutralizing Antibodies (Nab) of SHR-A2102		Up to 3 years.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Pemetrexed; Gemcitabine; Paclitaxel; Topotecan; Injections
• Other Study ID Numbers: SHR-A2102-310

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