Clinical trial NCT05766527: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum tolerated dose (MTD) of KM602, if any
timeFrame: Approximately 15 months
measure: Recommended Phase 2 dose (RP2D) of KM602
timeFrame: Approximately 15 months
measure: Incidence of treatment emergent adverse events
timeFrame: Through study completion, approximately 28 months
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Area Under the Curve (AUC) of KM602
timeFrame: Through study completion, approximately 28 months
measure: t1/2 of KM602
timeFrame: Through study completion, approximately 28 months
measure: Plasma clearance (CL) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Volume of distribution (V) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Anti-Drug Antibody of KM602
timeFrame: Through study completion, approximately 28 months
measure: Objective Response Rate (ORR) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Disease Control Rate (DCR) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Progression-free survival(PFS) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Duration of Response (DOR) of KM602
timeFrame: Through study completion, approximately 28 months
measure: Overall survival (OS) of KM602
timeFrame: Through study completion, approximately 28 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: