Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies

NCT05690581 | Recruiting Phase 1

• 1 other identifier: CM369-001
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumors and Hematologic Malignancies

Outcome Measures

Primary Outcomes (3)

• Adverse events (AEs)

  90 weeks

• Serious Adverse events (SAEs)

  90 weeks

• Dose limiting toxicities (DLTs)

  90 weeks

Secondary Outcomes (6)

• PK parameter: Peak Time (Tmax)

  90 weeks

• PK parameter: Half-life (t1/2)

  90 weeks

• PK parameter: Area Under the Curve (AUC)

  90 weeks

• PK parameters: Clearance (CL)

  90 weeks

• PK parameter: Apparent volume of distribution of steady state (Vss)

  90 weeks

Study Arms (2)

CM369 Ia Dose Escalation

EXPERIMENTAL

Dose escalation of CM369 as monotherapy

Drug: CM369

CM369 Ib Dose Expansion

EXPERIMENTAL

Dose expansion of CM369 as monotherapy

Drug: CM369

Interventions

CM369 DRUG

Specified dose on specified days.

CM369 Ia Dose Escalation; CM369 Ib Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy ≥12 weeks.
• Eastern Cooperative Oncology Group performance status of 0-1.
• 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 1.1.
• Have adequate organ function as described in the protocol.
• Male and female subjects ≥18 years of age and ≤ 75 years of age.
• This study enroll subjects with recurrent/refractory hematological tumors.
• The subjects must have measurable lesions.
• Positive CCR8in tumor tissues of subjects.
• Eastern Cooperative Oncology Group performance status (ECOG) of ≤2, and had a Life expectancy of at least 3 months.
• Adequate hematological function, defined as protocol.
• Subjects with normal coagulation function, defined as protocol.
• Adequate hepatic, renal and cardiac functions, defined as protocol.
• Subjects voluntarily signed informed consent form (ICF) and written informed consent must be obtained prior to performing any study-related procedure.

You may not qualify if:

• 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.
• Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.
• Has a history of severe allergic reactions to monoclonal antibodies.
• Subjects with any mental or cognitive impairment that may limit their understanding, implementation.
• Previous treatment with immune checkpoint inhibitors
• Autologous hematopoietic stem cell transplantation within 100 days prior to first investigational medications dose, or history of allogeneic hematopoietic stem cell transplantation.
• Subjects currently suffering from acute graft-versus-host disease (GVHD) or active chronic GVHD.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (3)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ruihua Xu

CONTACT

13922296676; xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: February 23, 2023
• Primary Completion: October 30, 2025
• Study Completion: February 28, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)