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Not yet recruitingNCT05766527Updated Mar 13, 2023

A Study of KM602 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of KM602 in Advanced Solid Tumor, sponsored by Xuanzhu Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Xuanzhu Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Solid Tumor

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    KM602 monotherapy

    Dose escalation and expansion

    Biological: KM602

Interventions

  • BiologicalKM602

    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.

05

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD) of KM602, if any

    Determined by the frequency of dose-limiting toxicities during dose-escalation

    Time frame: Approximately 15 months

  2. Recommended Phase 2 dose (RP2D) of KM602

    Determined by the frequency of dose-limiting toxicities during dose-escalation

    Time frame: Approximately 15 months

  3. Incidence of treatment emergent adverse events

    Severity graded per CTCAE version 5.0

    Time frame: Through study completion, approximately 28 months

Secondary outcomes

  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

06

Study locations

1 site
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
07

Registry details

Key details

Study ID
NCT05766527
Lead sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Apr 2023 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 13, 2023

Study contacts

Xingming Fan
Contact
fanxingming@xuanzhubio.com
086-18513114991

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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