Testing ZL-6201 for safety and early activity in sarcoma and other solid tumors
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
This trial will see if the antibody-drug conjugate ZL-6201 is safe and shows early anti-cancer activity in adults with sarcoma or certain other advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zai Lab (Hong Kong), Ltd. Industry-sponsored |
| Locations | 2 sites (Sarasota, Florida and 1 other locations) |
| Trial ID | NCT07374848 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter Phase 1a/b study gives escalating doses of ZL-6201 to adults with unresectable or metastatic sarcoma and selected solid tumors to characterize safety, tolerability, pharmacokinetics, and initial anti-tumor activity. Participants must have measurable disease, ECOG performance status 0–1, adequate organ and marrow function, be negative for HIV/HBV/HCV, and provide a tumor biopsy or archival tissue. The design includes dose-escalation followed by expansion cohorts in selected tumor types, with regular imaging per RECIST v1.1 and scheduled PK sampling. Safety events, lab results, and tumor responses will be tracked to establish a recommended dose for future studies.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced unresectable or metastatic sarcoma or selected epithelial solid tumors, ECOG 0–1, at least one measurable lesion, limited prior systemic therapy (≤2 lines for sarcoma; ≤3 for other selected tumors), and willing to provide tumor tissue are the intended participants.
Not a fit: Patients with poor performance status, significant organ dysfunction, active HIV/HBV/HCV infection, or those who have received more prior lines of therapy than allowed are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, ZL-6201 could provide a new targeted treatment option that shrinks tumors or slows progression in some patients with LRRC15-expressing sarcomas and related solid tumors.
How similar studies have performed: Other early-phase antibody-drug conjugates targeting LRRC15 have shown initial signals of activity in sarcoma in Phase 1 trials, but the approach remains experimental and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sarasota, Florida and 1 other locations
- Zai Lab Site 02026 — Sarasota, Florida, United States (Recruiting)
- Zai Lab Site 02006 — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: ZL-6201-001 Study Team
- Email: ZL-6201-001@zailaboratory.com
- Phone: (510)-316-3502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.