Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies
NCT ID: NCT05690581
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
146 participants
INTERVENTIONAL
2023-02-23
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CM369 Ia Dose Escalation
Dose escalation of CM369 as monotherapy
CM369
Specified dose on specified days.
CM369 Ib Dose Expansion
Dose expansion of CM369 as monotherapy
CM369
Specified dose on specified days.
Interventions
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CM369
Specified dose on specified days.
Eligibility Criteria
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Inclusion Criteria
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.
1. Male and female subjects ≥18 years of age and ≤ 75 years of age.
2. This study enroll subjects with recurrent/refractory hematological tumors.
3. The subjects must have measurable lesions.
4. Positive CCR8in tumor tissues of subjects.
5. Eastern Cooperative Oncology Group performance status (ECOG) of ≤2, and had a Life expectancy of at least 3 months.
6. Adequate hematological function, defined as protocol.
7. Subjects with normal coagulation function, defined as protocol.
8. Adequate hepatic, renal and cardiac functions, defined as protocol.
9. Subjects voluntarily signed informed consent form (ICF) and written informed consent must be obtained prior to performing any study-related procedure.
10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to receiving the first dose of study medication.
11. WOCBP or male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception during the study and for 6 months after the last dose, and must not donate eggs or sperms during this period.
12. Female subjects were not allowed to breastfeed during the study and for at least 6 months after the last dose of study medication.
Exclusion Criteria
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.
1. Previous treatment with immune checkpoint inhibitors
2. Autologous hematopoietic stem cell transplantation within 100 days prior to first investigational medications dose, or history of allogeneic hematopoietic stem cell transplantation.
3. Subjects currently suffering from acute graft-versus-host disease (GVHD) or active chronic GVHD.
4. Have had any therapy directed against the subject's underlying cancer within 28 days prior to first investigational medications dose.
5. Received other clinical trial drugs within 28 days prior to first investigational medications dose.
6. Subjects who experienced major organ surgery (except for needle biopsy) or significant trauma within 28 days prior to first investigational medications administration, or who need selected surgical procedures during the study.
7. Subjects who have been vaccinated with live attenuated vaccine within 28 days prior to first investigational medications administration.
8. Clinical evidence of central nervous system (CNS) metastasis will be excluded.
9. Previous or concomitant with CNS diseases.
10. History of another primary malignancy not in remission for at least 2 years.
11. Any severe active infection requiring systemic antimicrobial therapy.
12. Active hepatitis B or C virus infection.
13. History of immunodeficiency, including human immunodeficiency virus (HIV) antibody positive or known syphilis infection.
14. History of severe cardiovascular and cerebrovascular diseases.
15. Subjects who currently or have suffered from severe interstitial lung disease.
16. The toxicity of previous anti-tumor therapy is still ≥ grade 2 at enrollment.
17. History of severe bleeding disorders,.
18. Known alcohol or drug dependence.
19. Subjects with mental disorders or poor compliance.
20. Pregnant or lactating female subjects.
21. Any other condition that, in the opinion of the investigator or project clinician, would interfere with a subject's ability to receive or complete the study.
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Jilin Cancer Hospital
Changchun, Jilin, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Ruihua Xu
Role: primary
Ying Cheng
Role: primary
Liqun Zou
Role: primary
Lin Wang
Role: backup
Other Identifiers
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CM369-001
Identifier Type: -
Identifier Source: org_study_id