A Study of KM602 in Patients With Advanced Solid Tumors

Xuanzhu Biopharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Biological: KM602

Study type: Interventional

Funder types: Industry

Identifiers

NCT05766527

KM602-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

KM602 monotherapy

Experimental group

Description:

Dose escalation and expansion

Treatment:

Biological: KM602