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

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

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.

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

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