A Study of KM602 in Patients With Advanced Solid Tumors

Official title

A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors

Overview

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.

Interventions

• 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.

Primary outcome measures

• Maximum tolerated dose (MTD) of KM602, if any [Time frame: Approximately 15 months]
• Recommended Phase 2 dose (RP2D) of KM602 [Time frame: Approximately 15 months]
• Incidence of treatment emergent adverse events [Time frame: Through study completion, approximately 28 months]

Secondary outcome measures (11)

• Maximum Plasma Concentration (Cmax) of KM602 [Time frame: Through study completion, approximately 28 months]
• Area Under the Curve (AUC) of KM602 [Time frame: Through study completion, approximately 28 months]
• t1/2 of KM602 [Time frame: Through study completion, approximately 28 months]
• Plasma clearance (CL) of KM602 [Time frame: Through study completion, approximately 28 months]
• Volume of distribution (V) of KM602 [Time frame: Through study completion, approximately 28 months]
• Anti-Drug Antibody of KM602 [Time frame: Through study completion, approximately 28 months]
• Objective Response Rate (ORR) of KM602 [Time frame: Through study completion, approximately 28 months]
• Disease Control Rate (DCR) of KM602 [Time frame: Through study completion, approximately 28 months]
• Progression-free survival(PFS) of KM602 [Time frame: Through study completion, approximately 28 months]
• Duration of Response (DOR) of KM602 [Time frame: Through study completion, approximately 28 months]
• Overall survival (OS) of KM602 [Time frame: Through study completion, approximately 28 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT05766527 · KM602-1001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗