Combination of RC48 and Tislelizumab for treating recurrent cervical cancer

A Single-arm, Single Center, Phase II Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

This study is testing a new combination of two drugs, RC48 and Tislelizumab, to see if it can help people with recurrent cervical cancer who have not had success with their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: Tislelizumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06063018 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of RC48 combined with Tislelizumab as a second-line treatment for patients with HER2 expression in recurrent cervical cancer. It is a single-arm, single-center Phase 2 study that includes a safety induction period for the first six subjects to monitor for dose-limiting toxicity. If significant toxicity is observed, the dosage will be adjusted for subsequent patients. The study aims to provide a new treatment option for patients who have not responded to first-line therapies.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with HER2-positive recurrent cervical cancer who have a performance status of 0 or 1.

Not a fit: Patients with a history of other malignant tumors or those who do not meet the HER2 expression criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with recurrent cervical cancer expressing HER2.

How similar studies have performed: While this approach is novel in the context of recurrent cervical cancer, similar combinations have shown promise in other cancers, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Female subjects aged from 18 to 75 years old；
2. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1；
3. Have a life expectancy of at least 6 months, in the opinion of the investigator；
4. Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer;
5. Have measurable disease assessable by RECIST v1.1；
6. 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)；
7. Negative blood pregnancy test at Screening for women of childbearing potential；Highly effective contraception for female subjects if the risk of conception exists；

Exclusion Criteria:

1. 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；
2. 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；
3. 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)；
4. 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；
5. Previous or current congenital or acquired immunodeficiency disease；
6. Previous treatment with other antibody-coupled drugs；
7. Has not recovered from surgery, such as the presence of unhealed incisions or serious postoperative complications；
8. The patient had a known or suspected allergy to the experimental drug；
9. The New York College of Cardiology (NYHA) classiifies heart failure as grade 3 and above；
10. 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);
11. Other significant clinical and laboratory abnormalities considered to affect safety assessment, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.； Other conditions deemed unsuitable for inclusion by the researchers；

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lei Li, PhD — Peking Union Medical College Hospital
• Study coordinator: Lei Li, PhD

Conditions Cervical Cancer Recurrent