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

Summary

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.

Eligibility

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

Conditions3

Interventions1

Locations2 sites

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