Clinical trial · Interventional
A Study of YL242 in Subjects With Advanced Solid Tumors
A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.
NCT07197827CI-TRIAL-00099648recruitingPhase 1 / Phase 2ClinicalTrials.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)
This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| YL242 | Drug | — | UNRESOLVED |
| YL242; 5-FU; LV | Drug | — | UNRESOLVED |
| YL242; Pembrolizumab | Drug | — | UNRESOLVED |
| YL242; Pembrolizumab; 5-FU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1 and Part 2: Mono Dose Escalation & Expansion
- description
- Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
- interventionNames
- Drug: YL242
- type
- EXPERIMENTAL
- label
- Part 3 and 4: Combination Dose Escalation & Expansion
- description
- Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.
- interventionNames
- Drug: YL242; Pembrolizumab
- type
- EXPERIMENTAL
- label
- Part 5: Combination Dose Optimization and Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate organ and bone marrow function * Tumor type: Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy; Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy Exclusion Criteria: * Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases * Clinically significant concomitant pulmonary disease * A history of leptomeningeal carcinomatosis or carcinomatous meningitis * Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
References
Publications (0)
Data not yet available
No reference posted for this study.