SHR-7367 combined with other anti-cancer agents for adults with advanced solid tumors.

A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors

This trial will test whether SHR-7367 given with standard anti-cancer drugs is safe and shows early signs of benefit in adults with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07229586 on ClinicalTrials.gov

What this trial studies

This phase 1/2 study uses dose-escalation and expansion cohorts to test SHR-7367 in combination with antineoplastic agents including SHR-1316, paclitaxel, and gemcitabine. The main goals are to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) and to collect early safety and efficacy signals. Eligible adults must have measurable advanced solid tumors, ECOG 0–1, and adequate organ and marrow function. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital and enrolls patients aged 18–75.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with advanced solid tumors, ECOG performance status 0–1, at least one measurable lesion per RECIST v1.1, and adequate organ and marrow function.

Not a fit: Patients with known severe hypersensitivity to study drugs, uncontrolled psychiatric illness or substance abuse, recent participation in another clinical trial, or very poor organ function or performance status are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that is better tolerated or more effective for some patients with advanced solid tumors.

How similar studies have performed: Combining novel targeted or antibody drugs with chemotherapy has produced mixed early-phase signals in other cancers but has not yet demonstrated consistent large-scale success.

Eligibility criteria

Inclusion Criteria:

1. Be able and willing to provide a written informed consent.
2. Age 18-75 years old (inclusive) at the time of signing the informed consent form.
3. ECOG performance status 0-1.
4. Life expectancy is not less than 12 weeks.
5. At least one measurable lesion per RECIST v1.1.
6. Adequate organ and marrow function as defined by the protocol.

Exclusion Criteria:

1. Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
2. Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
3. Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
4. Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
5. Active HBV/HCV/HIV infection.
6. Untreated and/or uncontrolled brain metastases.
7. Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Botao Zhu

Conditions: Solid Tumor