RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

NCT06063018 | Recruiting Phase 2

• 1 other identifier: K3956
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.

Conditions

Cervical Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (4)

• Overall Survival(OS)

  up to 3 years

• Progression-free survival(PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Disease Control Rate (DCR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Duration of response（DOR）

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Study Arms (1)

RC48 + Tislelizumab

EXPERIMENTAL

Durg：RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Durg ：Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.

Drug: RC48 + Tislelizumab

Interventions

RC48 + Tislelizumab DRUG

RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.

RC48 + Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Female subjects aged from 18 to 75 years old；
• Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1；
• Have a life expectancy of at least 6 months, in the opinion of the investigator；
• Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer;
• Have measurable disease assessable by RECIST v1.1；
• Adequate haematological, hepatic and renal functions defined by the protocol； Pathologically diagnosed patients with HER2 expression （defined as: IHC 3+ or IHC 2+ or HC 1+）advanced cervical cancer ；Note：It is also acceptable if the subject has previous test results (confirmed by the investigator)；
• Negative blood pregnancy test at Screening for women of childbearing potential；Highly effective contraception for female subjects if the risk of conception exists；

You may not qualify if:

• History of malignant tumors other than cervical cancer, except for the following two cases：a. The patient had received a potentially curative treatment and had no evidence of the disease for 5 years；b. Successful resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, and other carcinoma in situ was received；
• Previous malignant disease (other than cervical cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)Previous stem cell allogeneic or parenchymal organ transplants；
• Patients who had previously received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) less than 4 weeks before the use of this study, or adverse events caused by previous treatment did not recover to ≤CTCAE grade 1 (except for alopecia and pigmentation)；
• Had received a live vaccine within 4 weeks prior to the start of study dosing or planned to receive any vaccine (except for COVID-19 vaccine) during the study period；
• Previous or current congenital or acquired immunodeficiency disease；
• Previous treatment with other antibody-coupled drugs；
• Has not recovered from surgery, such as the presence of unhealed incisions or serious postoperative complications；
• The patient had a known or suspected allergy to the experimental drug；
• The New York College of Cardiology (NYHA) classiifies heart failure as grade 3 and above；
• Severe infections that are active or poorly controlled clinically; Active infections, including: a. HIV (HIV1/2 antibody) positive; b. Active hepatitis B (HBsAg positive or HBV DNA \> 2000IU/ml and abnormal liver function); c. Active hepatitis C (HCV antibody positive or ≥103 copies /ml of HCV RNA and abnormal liver function); d. active tuberculosis; d. Other uncontrolled active infections (CTCAE V5.0 \> Grade 2);

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

RC48 antibody; tislelizumab

Study Officials

• Lei Li, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, PhD

CONTACT

13911988831; lileigh@163.com

Xiao Shang, PhD

CONTACT

13810073050; shang.mm@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: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 2, 2023
• Study Start: August 16, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CN (1)