Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CM369 Ia Dose Escalation Dose escalation of CM369 as monotherapy |
Drug: CM369
Specified dose on specified days.
|
| Experimental: CM369 Ib Dose Expansion Dose expansion of CM369 as monotherapy |
Drug: CM369
Specified dose on specified days.
|
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) [90 weeks]
- Serious Adverse events (SAEs) [90 weeks]
- Dose limiting toxicities (DLTs) [90 weeks]
Secondary Outcome Measures
- 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]
- Immunogenicity: Incidence of anti-CM369 antibody [90 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Life expectancy ≥12 weeks.
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Eastern Cooperative Oncology Group performance status of 0-1.
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Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
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Agree to provide archived tumor tissue samples of primary or metastatic lesions.
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Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.
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Have adequate organ function as described in the protocol.
Exclusion Criteria:
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Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
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Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
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Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
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Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
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Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.
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HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.
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History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.
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Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.
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Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.
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Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.
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Has a history of severe allergic reactions to monoclonal antibodies.
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Subjects with any mental or cognitive impairment that may limit their understanding, implementation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
| 2 | Jilin Cancer Hospital | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CM369-001