Clinical Trials in China / NCT07374848
Recruiting
Phase 1
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
NCT07374848 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid TumorsSarcomas
Investigational drug(s) / intervention(s)
ZL-6201
ZL-6201: ZL-6201 as a single-agent
Study 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
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities — 1 cycle of study treatment (each cycle is 21 days)
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only. - Incidence of Treatment Emergent Adverse Events — 36 months
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion. - Incidence of Serious adverse events — 36 months
Number of subjects with Serious Adverse Events through dose escalation and expansion. - Number of participants with clinical laboratory abnormalities — 36 months
- Number of participants with vital sign abnormalities — 36 months
Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute - Number of participants with electrocardiogram (ECG) abnormalities — 36 months
ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Zai Lab Site 02003 | Los Angeles | California | Recruiting |
| Zai Lab Site 02030 | New Haven | Connecticut | Recruiting |
| Zai Lab Site 02026 | Sarasota | Florida | Recruiting |
| Zai Lab Site 02005 | St Louis | Missouri | Recruiting |
| Zai Lab Site 02002 | New York | New York | Recruiting |
| Zai Lab Site 02006 | Fairfax | Virginia | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | Recruiting |
More Zai Lab (Shanghai) Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07374848 on ClinicalTrials.gov ↗ ← All trials in China