Clinical trial · Interventional
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected 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
NCT07374848CI-TRIAL-00119169recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcomas | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZL-6201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZL-6201
- description
- ZL-6201 as a single agent
- interventionNames
- Drug: ZL-6201
Primary outcomes (6)
- measure
- Incidence of Dose Limiting Toxicities
- timeFrame
- 1 cycle of study treatment (each cycle is 21 days)
- description
- Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
- measure
- Incidence of Treatment Emergent Adverse Events
- timeFrame
- 36 months
- description
- Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.