A Study of SHR-7367 With Anti-tumor Agents in Patients With 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
1 other identifier
interventional
100
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 19, 2025
December 1, 2025
2 years
November 13, 2025
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
Up to 28 days.
Stage 1 (IB Period): Adverse events (AEs).
About 1 year.
Stage 1 (IB Period): Serious adverse events (SAEs).
About 1 year.
Phase II: Investigator-assessed objective response rate (ORR).
Assessed every 6 weeks, about 1 year.
Secondary Outcomes (5)
Investigator-assessed objective response rate (ORR).
Assessed every 6 weeks, about 1 year.
Disease control rate (DCR).
Assessed every 6 weeks, about 1 year.
Duration of response (DoR).
Assessed every 6 weeks, about 1 year.
Progression Free Survival (PFS).
Assessed every 6 weeks, about 1 year.
Incidence and severity of Adverse events (AEs).
Assessed approximately once every 1 month, about 1 year.
Study Arms (3)
SHR-7367 + SHR-1316 Group
EXPERIMENTALSHR-7367 combined with SHR-1316.
SHR-7367 + SHR-1316 + AG Group
EXPERIMENTALSHR-7367 combined with SHR-1316 and AG.
SHR-7367 + AG Group
EXPERIMENTALSHR-7367 combined with AG.
Interventions
SHR-7367 injection.
Paclitaxel for injection (Albumin Bound).
Gemcitabine Hydrochloride for injection.
Eligibility Criteria
You may qualify if:
- 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.
- At least one measurable lesion per RECIST v1.1.
- Adequate organ and marrow function as defined by the protocol.
You may not qualify if:
- 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.
- Active HBV/HCV/HIV infection.
- Untreated and/or uncontrolled brain metastases.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 19, 2025
Record last verified: 2025-12