An Open-label, Multi-center Phase II Study to Evaluate the Safety, Tolerablity, Pharmacokinetics, and Efficacy of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Sujbects With Advanced Solid Tumors

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country20 target enrollmentDecember 2024

ConditionsAdvanced Solid Tumors

InterventionsSHR-4602

DrugsSHR-4602

Overview

Phase: Phase 2
Intervention: SHR-4602
Conditions: Advanced Solid Tumors
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: ORR by investigator assessment
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

December 2024

End Date

April 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-80 years old;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;
•Provide archived or fresh tumor tissue；HER2 expression is required for subjects in Stage I;
•At least one measurable lesion according to RECIST v1.1；
•Expected survival ≥12 weeks
•Good level of organ function；
•Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating. Male subjects whose partners are women of childbearing age and female subjects who are fertile must agree to avoid sperm or egg donation during the treatment period until 8 months after the last dose of the investigational drug;
•Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；

Exclusion Criteria

•Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
•Subjects with peripheral neuropathy；
•Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;
•Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
•Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment;
•Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;
•Toxicity and/or complications of previous antitumor therapy has not resolved to NCI-CTCAE level ≤1 or exclusion criteria；
•Have the following lung diseases or medical history: (1) known or suspected interstitial lung disease; (2) moderate to severe lung diseases that seriously affect lung function within the past 3 months; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors.
•Stage 2: ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
•Have any active, known or suspected autoimmune diseases;

Arms & Interventions

SHR-4602

Intervention: SHR-4602

Outcomes

Primary Outcomes

ORR by investigator assessment

Time Frame: Up to approximately 5 years;

ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years;