A Study of KM602 in Patients With Advanced Solid Tumors

NCT05766527 | Not Yet Recruiting Phase 1

• 1 other identifier: KM602-1001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) of KM602, if any

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

  Approximately 15 months

• Recommended Phase 2 dose (RP2D) of KM602

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

  Approximately 15 months

• Incidence of treatment emergent adverse events

  Severity graded per CTCAE version 5.0

  Through study completion, approximately 28 months

Secondary Outcomes (11)

• Maximum Plasma Concentration (Cmax) of KM602

  Through study completion, approximately 28 months

• Area Under the Curve (AUC) of KM602

  Through study completion, approximately 28 months

• t1/2 of KM602

  Through study completion, approximately 28 months

• Plasma clearance (CL) of KM602

  Through study completion, approximately 28 months

• Volume of distribution (V) of KM602

  Through study completion, approximately 28 months

Study Arms (1)

KM602 monotherapy

EXPERIMENTAL

Dose escalation and expansion

Biological: KM602

Interventions

KM602 BIOLOGICAL

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.

KM602 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• All patients must have at least one measurable lesion at baseline according to RECIST v1.1
• ECOG performance status of 0 or 1
• Life expectancy of ≥ 12 weeks
• Adequate baseline hematologic, renal, and hepatic function

You may not qualify if:

• Patients with meningeal metastasis or symptomatic central nervous system metastasis
• Any second malignancy active within the previous 5 years
• Any active, known, or suspected autoimmune disease
• Active or prior pneumonitis or interstitial lung disease
• Prior organ allograft or allogeneic hematopoietic stem cell transplantation
• 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
• Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
• History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
• 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
• Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
• Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
• Active infection requiring therapy at the time of the first dose of KM602
• Pregnancy or breastfeeding
• 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.

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Central Study Contacts

Xingming Fan

CONTACT

086-18513114991; fanxingming@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 13, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2023

Record last verified: 2023-02

Locations

CN (1)