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Recruiting NCT07229586

A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors

Phase I / Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-7367 Injection, SHR-1316 Injection, Paclitaxel for Injection, Gemcitabine Hydrochloride for Injection.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug SHR-7367 Injection
    SHR-7367 injection.
  • Drug SHR-1316 Injection
    SHR-1316 injection.
  • Drug Paclitaxel for Injection
    Paclitaxel for injection (Albumin Bound).
  • Drug Gemcitabine Hydrochloride for Injection
    Gemcitabine Hydrochloride for injection.

Primary outcome measures

  • Stage 1 (IB Period): Dose-limiting toxicity (DLT). [Time frame: Up to 28 days.]
  • Stage 1 (IB Period): Adverse events (AEs). [Time frame: About 1 year.]
  • Stage 1 (IB Period): Serious adverse events (SAEs). [Time frame: About 1 year.]
  • Phase II: Investigator-assessed objective response rate (ORR). [Time frame: Assessed every 6 weeks, about 1 year.]
Secondary outcome measures (5)
  • Investigator-assessed objective response rate (ORR). [Time frame: Assessed every 6 weeks, about 1 year.]
  • Disease control rate (DCR). [Time frame: Assessed every 6 weeks, about 1 year.]
  • Duration of response (DoR). [Time frame: Assessed every 6 weeks, about 1 year.]
  • Progression Free Survival (PFS). [Time frame: Assessed every 6 weeks, about 1 year.]
  • Incidence and severity of Adverse events (AEs). [Time frame: Assessed approximately once every 1 month, about 1 year.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07229586 · HRS-4642-205-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗