Actively Recruiting
Study of CM369 to Assess Safety, Tolerability, and Effects in Advanced Solid Tumors and Blood Cancers A Nonrandomized, Open-label Phase I Clinical Trial
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-12-27
146
Participants Needed
3
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CM369 in a nonrandomized, open-label, multicenter Phase I trial to study its safety, tolerability, pharmacokinetics, and efficacy in adults with advanced solid tumors and hematologic malignancies. The trial includes subjects with locally advanced unresectable or metastatic solid tumors, as well as recurrent or refractory hematological tumors, to better understand how CM369 performs in these conditions. Participants receive CM369 drug doses on specified days as part of the treatment. The study monitors how the drug behaves in the body, its safety profile, and its effects on the tumors. The trial is conducted at multiple centers with no randomization or blinding. During the study, participants undergo regular assessments including monitoring for adverse events, serious adverse events, and dose-limiting toxicities over a 90-week period. Researchers also evaluate tumor response and organ function. Participants provide archived tumor tissue samples and must comply with safety and monitoring procedures throughout the study duration.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 for solid tumor group
- Cytology or histologically confirmed locally advanced unresectable or metastatic solid tumors
- Agree to provide archived tumor tissue samples
- At least one measurable or evaluable lesion per RECIST 1.1 for Phase Ia solid tumor group
- Adequate organ function as defined in the protocol
- Age between 18 and 75 years for hematologic malignancies group
- Recurrent or refractory hematological tumors
- Measurable lesions for hematologic malignancies group
- Positive CCR8 in tumor tissues
- ECOG performance status of 0-2 and life expectancy of at least 3 months for hematologic malignancies group
- Adequate hematological, hepatic, renal, cardiac, and coagulation function as defined in the protocol
- Signed informed consent form prior to any study-related procedure
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Willingness to use contraception during the study and for 6 months after last dose
- Female subjects must not breastfeed during the study and for 6 months after last dose
You will not qualify if you...
- Primary central nervous system tumors or unstable CNS metastases
- Uncontrollable or major cardiovascular disease
- Active autoimmune disease or history with risk of recurrence
- Active or history of interstitial lung disease or non-infectious pneumonia
- Active infections requiring intravenous systemic treatment within 14 days prior to first drug dose
- HIV infection; Hepatitis C virus antibody positive or infection
- History of active bleeding within 2 months before screening or bleeding related to anticoagulants
- Not recovered to CTCAE Grade 1 or better from adverse events due to previous cancer therapies
- Systemic immunosuppressive drugs within 14 days prior to first drug dose
- Need for systemic corticosteroids or immunosuppressive agents within 14 days prior to first dose
- History of severe allergic reactions to monoclonal antibodies
- Mental or cognitive impairments limiting understanding or implementation
- Previous immune checkpoint inhibitor treatment for hematologic malignancies
- Recent hematopoietic stem cell transplantation within 100 days or history of allogeneic transplantation
- Acute or active chronic graft-versus-host disease
- Cancer therapy within 28 days prior to first investigational dose
- Participation in other clinical trials within 28 days prior to first investigational dose
- Major surgery or significant trauma within 28 days prior to first drug administration
- Vaccination with live attenuated vaccine within 28 days prior to first drug administration
- CNS metastasis or diseases
- History of another primary malignancy not in remission for at least 2 years
- Severe active infections requiring systemic antibiotics
- Active hepatitis B or C virus infection
- Immunodeficiency, including HIV antibody positive or known syphilis infection
- Severe cardiovascular and cerebrovascular diseases
- Severe interstitial lung disease
- Toxicity from prior anti-tumor therapy still at Grade 2 or worse
- History of severe bleeding disorders
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnancy or lactation
- Any condition that might interfere with receiving or completing the study according to investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
3
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
R
Ruihua Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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