Clinical trial · Interventional
A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors
A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of YL201 in Combination With Ivonescimab in Patients With Advanced Solid Tumors
NCT07208773CI-TRIAL-00115182recruitingPhase 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 study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.
Conditions
Conditions (3)
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivonescimab | Drug | — | UNRESOLVED |
| YL201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1： Safety run-in
- description
- Multiple dose levels of YL201 will be explored in combination with Ivonescimab administered intravenously (IV) at a fixed dose.Participants receive YL201 and Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.
- interventionNames
- Drug: YL201
- Drug: Ivonescimab
- type
- EXPERIMENTAL
- label
- Phase 2： Dose expansion
- description
- YL201 will be administered at the selected RDE in combination with Ivonescimab administered IV at a fixed dose. Participants receive YL201+ Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.
- interventionNames
- Drug: YL201
- Drug: Ivonescimab
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC. 3. ECOG PS score is 0 or 1. 4. Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements. Exclusion Criteria: 1. Suitable for local curative treatment. 2. Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs). 3. Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors. 4. Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \[anti-PD-(L)1\] or other immune checkpoint inhibitors. 5. History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization. 6. Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels. 7. Active autoimmune disease requiring systemic treatment. 8. Brain metastases or spinal cord compression. 9. Patients with uncontrolled or clinically significant cardiovascular diseases. 10. Clinically significant concurrent pulmonary diseases. 11. Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/ exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.