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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
