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 groupSponsors and collaborators
Zai Lab (Shanghai) Co., Ltd.
Lead sponsor
Zai Lab (US) LLC
Collaborator
Source ClinicalTrials.gov