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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

ZL-6201

ZL-6201 as a single-agent

Locations (2)

Zai Lab Site 02026
Sarasota, Florida, United States
Zai Lab Site 02006
Fairfax, Virginia, United States