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A Study of KM602 in Patients 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: NCT05766527
Recruitment Status : Not yet recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Xuanzhu Biopharmaceutical Co., Ltd.

Study Description
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Brief Summary:
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Biological: KM602 Phase 1

Detailed Description:
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors
Estimated Study Start Date : April 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: KM602 monotherapy
Dose escalation and expansion
 Biological: KM602
Multiple dose levels of KM602 will be administered, including 0.01 mg/kg QW, 0.1 mg/kg QW, 0.6 mg/kg QW, 3 mg/kg QW, and 10 mg/kg QW. KM602 is administered intravenously once a week, and each cycle is 21 days.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of KM602, if any [ Time Frame: Approximately 15 months ]
    Determined by the frequency of dose-limiting toxicities during dose-escalation

  2. Recommended Phase 2 dose (RP2D) of KM602 [ Time Frame: Approximately 15 months ]
    Determined by the frequency of dose-limiting toxicities during dose-escalation

  3. Incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 28 months ]
    Severity graded per CTCAE version 5.0


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  2. Area Under the Curve (AUC) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  3. t1/2 of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  4. Plasma clearance (CL) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  5. Volume of distribution (V) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  6. Anti-Drug Antibody of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  7. Objective Response Rate (ORR) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  8. Disease Control Rate (DCR) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  9. Progression-free survival(PFS) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  10. Duration of Response (DOR) of KM602 [ Time Frame: Through study completion, approximately 28 months ]
  11. Overall survival (OS) of KM602 [ Time Frame: Through study completion, approximately 28 months ]

Eligibility Criteria
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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. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)
  2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1
  3. ECOG performance status of 0 or 1
  4. Life expectancy of ≥ 12 weeks
  5. Adequate baseline hematologic, renal, and hepatic function

Exclusion Criteria:

  1. Patients with meningeal metastasis or symptomatic central nervous system metastasis
  2. Any second malignancy active within the previous 5 years
  3. Any active, known, or suspected autoimmune disease
  4. Active or prior pneumonitis or interstitial lung disease
  5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation
  6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602
  7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
  8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
  9. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study
  10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
  11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
  12. Active infection requiring therapy at the time of the first dose of KM602
  13. Pregnancy or breastfeeding
  14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
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): NCT05766527


Contacts
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Contact: Xingming Fan 086-18513114991 fanxingming@xuanzhubio.com

Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Contact: Jun Guo    13911233048    guoj307@126.com   
Sponsors and Collaborators
Xuanzhu Biopharmaceutical Co., Ltd.
More Information
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Responsible Party: Xuanzhu Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05766527    
Other Study ID Numbers: KM602-1001
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: February 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