A Study of KM602 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05766527
• Other study ID #: KM602-1001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: Xingming Fan
• Phone: 086-18513114991
• Email: fanxingming[@]xuanzhubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanzhu Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of KM602, if any	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 15 months
Primary	Recommended Phase 2 dose (RP2D) of KM602	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 15 months
Primary	Incidence of treatment emergent adverse events	Severity graded per CTCAE version 5.0	Through study completion, approximately 28 months
Secondary	Maximum Plasma Concentration (Cmax) of KM602		Through study completion, approximately 28 months
Secondary	Area Under the Curve (AUC) of KM602		Through study completion, approximately 28 months
Secondary	t1/2 of KM602		Through study completion, approximately 28 months
Secondary	Plasma clearance (CL) of KM602		Through study completion, approximately 28 months
Secondary	Volume of distribution (V) of KM602		Through study completion, approximately 28 months
Secondary	Anti-Drug Antibody of KM602		Through study completion, approximately 28 months
Secondary	Objective Response Rate (ORR) of KM602		Through study completion, approximately 28 months
Secondary	Disease Control Rate (DCR) of KM602		Through study completion, approximately 28 months
Secondary	Progression-free survival(PFS) of KM602		Through study completion, approximately 28 months
Secondary	Duration of Response (DOR) of KM602		Through study completion, approximately 28 months
Secondary	Overall survival (OS) of KM602		Through study completion, approximately 28 months