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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Botao Zhu
• Email: botao.zhu.bz19@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.