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

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).

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: SHR-1316 Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: SHR-7367 Injection; Drug: Paclitaxel for Injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Botao Zhu; Phone Number: +86-0518-82342973; Email: botao.zhu.bz19@hengrui.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Principal Investigator: Jihui Hao
      • Contact: Jihui Hao; Phone Number: +86-022-23340123; Email: haojihui@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-7367 + SHR-1316 Group; SHR-7367 combined with SHR-1316.	Drug: SHR-1316 Injection; SHR-1316 injection.; Drug: SHR-7367 Injection; SHR-7367 injection.
Experimental: SHR-7367 + SHR-1316 + AG Group; SHR-7367 combined with SHR-1316 and AG.	Drug: SHR-1316 Injection; SHR-1316 injection.; Drug: Gemcitabine Hydrochloride for Injection; Gemcitabine Hydrochloride for injection.; Drug: SHR-7367 Injection; SHR-7367 injection.; Drug: Paclitaxel for Injection; Paclitaxel for injection (Albumin Bound).
Experimental: SHR-7367 + AG Group; SHR-7367 combined with AG.	Drug: Gemcitabine Hydrochloride for Injection; Gemcitabine Hydrochloride for injection.; Drug: SHR-7367 Injection; SHR-7367 injection.; Drug: Paclitaxel for Injection; Paclitaxel for injection (Albumin Bound).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed objective response rate (ORR).	Complete response + Partial response (CR+PR) based on RECIST v1.1.	Assessed every 6 weeks, about 1 year.
Disease control rate (DCR).	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1.	Assessed every 6 weeks, about 1 year.
Duration of response (DoR).	Time from documentation of tumor response to disease progression assessed among patients who had an objective response.	Assessed every 6 weeks, about 1 year.
Progression Free Survival (PFS).	Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.	Assessed every 6 weeks, about 1 year.
Incidence and severity of Adverse events (AEs).	Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.	Assessed approximately once every 1 month, about 1 year.

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Administration Routes; Drug Therapy; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Paclitaxel; Injections
• Other Study ID Numbers: HRS-4642-205-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No