Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ZL-6201
Treatment groups
180 Participants
are divided into 1 treatment groupLocations
6California
Zai Lab Site 0200390007, Los Angeles United States
Connecticut
Zai Lab Site 0203006510, New Haven United States
Florida
Zai Lab Site 0202634232, Sarasota United States
Missouri
Zai Lab Site 0200563160, St Louis United States
Sponsors and collaborators
Zai Lab (Shanghai) Co., Ltd.
Lead sponsor
Zai Lab (US) LLC
Collaborator
Source ClinicalTrials.gov