Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

Zai Lab

Status and phase: Begins enrollment this month; Phase 1

Conditions: Solid Tumors; Sarcomas

Treatments: Drug: ZL-6201

Study type: Interventional

Funder types: Industry

Identifiers

NCT07374848

ZL-6201-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.

Full description

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy > 3 months
• Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and/or metastatic sarcoma or a selected solid tumor
• Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample
• Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting
• Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting
• Participants must have at least one measurable target lesion as defined by RECIST v1.1
• Adequate organ and marrow function as listed per protocol
• Must be negative for HIV, HBV, and HCV

Exclusion criteria

• Participants with another known malignancy that has required treatment within the last 2 years
• Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
• Participants with leptomeningeal metastasis
• Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks
• Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
• Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
• Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
• Pregnant or nursing (lactating) women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

ZL-6201

Experimental group

Description:

ZL-6201 as a single agent

Treatment:

Drug: ZL-6201