A Study of KM602 in Patients With Advanced Solid Tumors

NCT ID: NCT05766527

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-12-31

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KM602 monotherapy

Dose escalation and expansion

Group Type: EXPERIMENTAL

KM602

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanzhu Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xingming Fan

Role: CONTACT

fanxingming@xuanzhubio.com

086-18513114991

Facility Contacts

Jun Guo

Role: primary

guoj307@126.com

13911233048

Other Identifiers

KM602-1001

Identifier Type: -

Identifier Source: org_study_id