The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC

NCT07172217 | Not Yet Recruiting Phase 2

• 1 other identifier: KYLL-202503-017-1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators: Primary evaluation indicator: Objective Response Rate (ORR) Secondary evaluation indicators: Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival \[mOS\] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).

Conditions

Recurrent Cervical Cancer

Keywords

RC48;QL1706;HER2-Expressing;Recidivation; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The proportion of subjects with complete response (CR) and partial response (PR) according RESIST 1.1 in total subjects.

  6 months after the last subject participating in

Secondary Outcomes (4)

• Progression-Free Survival

  Approximately 1 years after last participant enrollment.

• disease control rate (DCR)

  Approximately 1 years after last participant enrollment.

• duration of response (DOR)

  The time from the start of treatment to the first observation of response (Complete Response [CR] or Partial Response [PR]) that is ultimately confirmed (typically via a subsequent reassessment at least 4 weeks later, per RECIST criteria).

• overall survival (OS)

  Approximately 1 years after last participant enrollment.

Study Arms (1)

RC48 and QL1706

EXPERIMENTAL

Drug: RC48; Drug: QL1706

Interventions

RC48 DRUG

Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle

RC48 and QL1706

QL1706 DRUG

Drug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle

RC48 and QL1706

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily enroll in the study and sign a written informed consent form;
• Female patients aged 18 to 75 years (inclusive);
• Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or small cell (neuroendocrine) cervical cancer;
• Progressive disease or recurrent disease after first-line treatment for recurrent cervical cancer;
• Subjects can provide tumor specimens (paraffin blocks, formalin-fixed paraffin-embedded \[FFPE\] sections, or fresh tissue sections) from the primary or metastatic site for HER2 detection, with HER2 immunohistochemistry (IHC) test results of IHC 1+, 2+, or 3+ (previous test results confirmed by the investigator are also acceptable);
• Presence of at least one evaluable lesion (per RECIST 1.1 criteria);
• Expected survival time ≥ 6 months;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
• For female patients of childbearing potential (i.e., premenopausal or not surgically sterilized), the serum pregnancy test result within 7 days before the first administration of the study drug must be negative; and reliable contraceptive measures must be used during the study drug administration period and within 60 days after the last dose;
• Normal function of major organs, meeting the following criteria:
• Left ventricular ejection fraction (LVEF) ≥ 50%; Hemoglobin (Hb) ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelets (PLT) ≥ 100 × 10⁹/L; Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in the absence of liver metastasis, and ALT and AST ≤ 5 × ULN in the presence of liver metastasis; Serum creatinine (Scr) ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 40 mL/min calculated by the Cockcroft-Gault formula.

You may not qualify if:

• History of malignant tumors other than cervical cancer, except for the following two situations:
• Patients who have received potentially curative treatment and have no evidence of the disease for 5 years;
• Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, and other carcinoma in situ that have been successfully treated with resection;
• Previous allogeneic stem cell or solid organ transplantation;
• Previous systemic anti-tumor therapy (including traditional Chinese medicine with anti-tumor indications) completed less than 4 weeks before the first administration of the study drug, or patients whose adverse events caused by previous treatment have not recovered to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia and pigmentation);
• Vaccination with live vaccines within 4 weeks before the start of study drug administration, or planned receipt of any vaccines (except COVID-19 vaccines) during the study period;
• Previous or current history of congenital or acquired immunodeficiency diseases;
• Previous treatment with other antibody-drug conjugates (ADCs);
• Patients with known or suspected history of allergy to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugates and anti-PD-1 drugs of the same class, or history of hypersensitivity to chimeric/humanized antibodies or fusion proteins, or allergy to the excipients of the study drug;
• Other significant clinical and laboratory abnormalities that the investigator deems may affect safety evaluation, such as uncontrolled diabetes mellitus, chronic kidney disease, peripheral neuropathy of Grade 2 or higher (per CTCAE V5.0), abnormal thyroid function, etc.;
• Heart failure of New York Heart Association (NYHA) Class 3 or higher;
• Severe infection in active stage or with poor clinical control; active infections include:
• Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
• Active hepatitis B (positive for hepatitis B surface antigen \[HBsAg\], or hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \> 2000 IU/ml with abnormal liver function);
• Active hepatitis C (positive for hepatitis C virus \[HCV\] antibodies, or HCV ribonucleic acid \[HCV RNA\] ≥ 10³ copies/ml with abnormal liver function);

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Ji'an, Shandong, 250000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Peng Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Zhao

CONTACT

18560081925; ericdareway@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gynecology

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)