Clinical trial · Interventional
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors
NCT06859762CI-TRIAL-00100857recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU with leucovorin | Drug | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| YL217 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combo-Dose Escalation,Backfill and Expansion
- description
- Participants will receive YL217 in combination of bevacizumab with or without 5-FU/LV
- interventionNames
- Drug: YL217
- Drug: Bevacizumab
- Drug: 5-FU with leucovorin
- type
- EXPERIMENTAL
- label
- Mono-Dose Escalation,Backfill and Expansion
- description
- Participants will receive YL217 monotherapy
- interventionNames
- Drug: YL217
Primary outcomes (3)
- measure
- Nature and frequency of dose-limiting toxicity(DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed of the study before the start of the study and voluntarily sign their name and date in the ICF * Able and willing to comply with protocol visits and procedures * Age≥ 18 years * ECOG PS of 0 or 1 * Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy * Adequate organ and bone marrow function. * Have at least 1 extracranial measurable tumor lesion. * Adequate archival formalin-fixed paraffin embedded (FFPE) tissue from prior biopsy. Exclusion Criteria: * Prior treatment with an agent targeting CDH17 * Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities. * Have received an ADC consisting of a topoisomerase I inhibitor. * Concurrent enrollment in another clinical study, unless it is an observational clinical study. * Inadequate washout period for prior anticancer treatment before the first dose of study drug * Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug. * Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug. * Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study. * Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis. * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. * A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis. * Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Uncontrolled third-space fluid that requires repeated drainage. * Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease. * An active tuberculosis based on medical history. * Known human immunodeficiency virus (HIV) infection. * Active hepatitis C infection.
References
Publications (0)
Data not yet available
No reference posted for this study.