A Study of KM602 in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Biological: KM602

• Registration Number: NCT05766527
• Lead Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

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.

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 Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Study Start: 2023-04
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KM602 monotherapy	KM602	Dose escalation and expansion

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 dose (RP2D) of KM602	Approximately 15 months	Determined by the frequency of dose-limiting toxicities during dose-escalation
Incidence of treatment emergent adverse events	Through study completion, approximately 28 months	Severity graded per CTCAE version 5.0
Maximum tolerated dose (MTD) of KM602, if any	Approximately 15 months	Determined by the frequency of dose-limiting toxicities during dose-escalation

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of KM602	Through study completion, approximately 28 months
Volume of distribution (V) of KM602	Through study completion, approximately 28 months
Anti-Drug Antibody of KM602	Through study completion, approximately 28 months
Disease Control Rate (DCR) of KM602	Through study completion, approximately 28 months
Overall survival (OS) 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
Objective Response Rate (ORR) of KM602	Through study completion, approximately 28 months
Duration of Response (DOR) of KM602	Through study completion, approximately 28 months
Area Under the Curve (AUC) of KM602	Through study completion, approximately 28 months
Progression-free survival(PFS) of KM602	Through study completion, approximately 28 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China