Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Purpose
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.
Conditions
- Solid Tumors
- Sarcomas
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ZL-6201 |
ZL-6201 as a single agent |
|
Recruiting Locations
Zai Lab Site 02006
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
Contact:
Site 02006
Site 02006
More Details
- Status
- Recruiting
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Detailed Description
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