A Nonrandomized, Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects with Advanced Solid Tumors and Hematologic Malignancies

Beijing InnoCare Pharma Tech Co., Ltd.3 sites in 1 country146 target enrollmentFebruary 23, 2023

ConditionsAdvanced Solid Tumors and Hematologic Malignancies

InterventionsCM369

DrugsCM369

Overview

Phase: Phase 1
Intervention: CM369
Conditions: Advanced Solid Tumors and Hematologic Malignancies
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 146
Locations: 3
Primary Endpoint: Adverse events (AEs)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.

Registry

clinicaltrials.gov

Start Date

February 23, 2023

End Date

February 28, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Solid tumor Inclusion Criteria:
•Life expectancy ≥12 weeks.
•Eastern Cooperative Oncology Group performance status of 0-
•Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
•Agree to provide archived tumor tissue samples of primary or metastatic lesions.
•Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.
•Have adequate organ function as described in the protocol.
•Hematologic Malignancies Inclusion Criteria:
•Male and female subjects ≥18 years of age and ≤ 75 years of age.
•This study enroll subjects with recurrent/refractory hematological tumors.

Exclusion Criteria

•Solid tumor Exclusion Criteria:
•Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
•Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
•Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
•Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
•Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.
•HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.
•History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.
•Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.
•Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.