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

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 : Recruiting
First Posted : January 19, 2023
Last Update Posted : December 13, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors and Hematologic Malignancies Drug: CM369 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 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 and Hematologic Malignancies
Actual Study Start Date : February 23, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : April 30, 2025

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

Solid tumor 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.

Hematologic Malignancies Inclusion Criteria:

  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:

Solid tumor 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.

Hematologic Malignancies Exclusion Criteria:

  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.

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 Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ruihua Xu         
China, Jilin
Jilin Cancer Hospital Recruiting
Changchun, Jilin, China, 130000
Contact: Ying Cheng    0431-80596315    JL.Cheng@163.com   
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Liqun Zou         
Contact: Lin Wang         
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
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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: December 13, 2023
Last Verified: December 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
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases