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NCT Number: NCT07418749

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Jihong Liu

CONTACT

[email protected]

+86-020-87341614

Jihong Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participate in the study voluntarily, sign the informed consent form.
  • 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.
  • Provide primary or metastatic tumor samples.
  • At least one measurable lesion (RECIST version 1.1).
  • ECOG 0~ 1.
  • With adequate organ functions.
  • Expected overall survival is ≥12 weeks.

Exclusion criteria

  • With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
  • With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
  • With a history of or concurrent other malignant tumor(s).
  • Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
  • With known or suspected interstitial lung disease.
  • With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
  • With poorly controlled cardiac clinical symptoms or diseases.
  • Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
  • With severe infections occurring within 1 month prior to randomization.
  • 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).
  • 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.
  • 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.
  • Have received systemic anti-tumor therapy within 28 days prior to randomization.
  • 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.
  • 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.

Treatment and study plan

SHR-A2102 for Injection

Drug

SHR-A2102 for injection.

Pemetrexed Disodium for Injection

Drug

Pemetrexed Disodium for injection.

Gemcitabine Hydrochloride for Injection

Drug

Gemcitabine Hydrochloride for injection.

topotecan hydrochloride for injection

Drug

Topotecan Hydrochloride for injection.

paclitaxel for injection (albumin bound)

Drug

Paclitaxel for injection (Albumin bound).

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 3 years.

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: Up to 3 years.

    Assessed by the investigator according to RECIST 1.1 criteria.

  2. Objective Response Rate (ORR)

    Time frame: Up to 3 years.

    Assessed by the investigator according to RECIST 1.1 criteria.

  3. Duration of response (DoR)

    Time frame: Up to 3 years.

    Assessed by the investigator according to RECIST 1.1 criteria.

  4. Disease control rate (DCR)

    Time frame: Up to 3 years.

    Assessed by the investigator according to RECIST 1.1 criteria.

  5. Adverse Events (AEs)

    Time frame: Up to 3 years.

    Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.

  6. Serious Adverse Events (AEs)

    Time frame: Up to 3 years.

    Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.

  7. Plasma concentrations of SHR-A2102

    Time frame: Up to 3 years.

    Pharmacokinetics (PK) traits of SHR-A2102.

  8. Plasma concentrations of SHR-A2102 metabolites

    Time frame: Up to 3 years.

    Pharmacokinetics (PK) traits of SHR-A2102.

  9. Incidence of Anti-Drug Antibody (ADA) of SHR-A2102

    Time frame: Up to 3 years.

  10. Incidence of Neutralizing Antibodies (Nab) of SHR-A2102

    Time frame: Up to 3 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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