A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
Eligibility criteria
Qualifiers
Be able and willing to provide a written informed consent.
Age 18-75 years old (inclusive) at the time of signing the informed consent form.
ECOG performance status 0-1.
Life expectancy is not less than 12 weeks.
Disqualifiers
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.
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.
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).
Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
Trial design
Treatments tested in this trial
- SHR-7367 Injection
- SHR-1316 Injection
- Paclitaxel for Injection
- Gemcitabine Hydrochloride for Injection
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov