SHR-7787 combined with other anti-cancer drugs for malignant solid tumors

A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors

This study will test whether giving SHR-7787 together with other anti-cancer medicines is safe and helps people with unresectable malignant solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT07268040 on ClinicalTrials.gov

What this trial studies

This Phase 2 study gives participants SHR-7787 together with one of several other anti-tumor agents (for example SHR-1316, SHR-4849, etoposide, or carboplatin) to see how the combinations perform. Eligible patients must have histologically or cytologically confirmed unresectable malignant solid tumors, at least one measurable lesion per RECIST 1.1, and ECOG performance status 0–1. Participants are monitored for safety, tolerability, and anti-tumor activity with regular imaging and clinical assessments. The trial requires adequate organ function and a minimum life expectancy of three months.

Who should consider this trial

Good fit: Ideal candidates have unresectable malignant solid tumors with at least one measurable lesion, ECOG 0–1, adequate organ function, and an expected survival of at least three months.

Not a fit: Patients with active CNS metastases, uncontrolled serious cardiovascular or cerebrovascular disease, uncontrolled large effusions, severe recent infections, active tuberculosis, or recent other malignancies are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the combinations could offer a new treatment option that improves tumor response or disease control for patients with hard-to-treat solid tumors.

How similar studies have performed: Combining targeted agents or chemotherapy has shown benefit in some solid tumors, but combinations specifically involving SHR-7787 are relatively novel and have limited published clinical data.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with histologically or cytologically confirmed unresectable solid tumors;
3. At least one measurable lesion was identified per RECIST 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined per protocol;
6. Minimum life expectancy of 3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases;
2. History of other malignancy within the past 5 years, with exceptions defined in the protocol;
3. Patients with uncontrolled cancer pain;
4. Patients with serious cardiovascular and/or cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections within 4 weeks prior to the first dose;
7. Active pulmonary tuberculosis infection;
8. History of immunodeficiency;
9. History of autoimmune diseases;
10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
11. Pregnant or nursing women, or planned to become pregnant during the study period;
12. Known allergic to any component of investigational drugs.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xianhua Qiu

Conditions Malignant Solid Tumors