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Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05690581
Recruitment Status : Not yet recruiting
First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Study Description
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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
Advanced Solid Tumors Drug: CM369 Phase 1

Study Design
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Study Type : Interventional
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 25, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : April 30, 2025
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: 90 weeks ]
  2. Serious Adverse events (SAEs) [ Time Frame: 90 weeks ]
  3. Dose limiting toxicities (DLTs) [ Time Frame: 90 weeks ]

Secondary Outcome Measures :
  1. PK parameter: Peak Time (Tmax) [ Time Frame: 90 weeks ]
  2. PK parameter: Half-life (t1/2) [ Time Frame: 90 weeks ]
  3. PK parameter: Area Under the Curve (AUC) [ Time Frame: 90 weeks ]
  4. PK parameters: Clearance (CL) [ Time Frame: 90 weeks ]
  5. PK parameter: Apparent volume of distribution of steady state (Vss) [ Time Frame: 90 weeks ]
  6. Immunogenicity: Incidence of anti-CM369 antibody [ Time Frame: 90 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Life expectancy ≥12 weeks.
  2. Eastern Cooperative Oncology Group performance status of 0-1.
  3. Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
  4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.
  5. Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.
  6. Have adequate organ function as described in the protocol.

Exclusion Criteria:

  1. Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
  2. Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
  3. Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
  4. Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
  5. Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.
  6. HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.
  7. History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.
  8. Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.
  9. Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.
  10. Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.
  11. Has a history of severe allergic reactions to monoclonal antibodies.
  12. Subjects with any mental or cognitive impairment that may limit their understanding, implementation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05690581


Contacts
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Contact: Ruihua Xu 13922296676 xurh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Contact: Ruihua Xu         
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Contact: Ying Cheng    0431-80596315    JL.Cheng@163.com   
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
More Information
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Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT05690581    
Other Study ID Numbers: CM369-001
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms