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Recruiting Phase 1/2

A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors

NCT07208773 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-10-29
Last updated
2026-06-18

Condition(s) studied

Advanced Solid TumorsNon Small Cell Lung CancerSmall Cell Lung Cancer

Investigational drug(s) / intervention(s)

YL201 →Ivonescimab →

YL201: YL201 will be administered as IV infusion

Ivonescimab: Ivonescimab will be administered as IV infusion.

Study summary

This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and severity of adverse events (AEs) — Approximately within 36 months
    AEs are assessed based on NCI CTCAE v5.0.
  • Maximum tolerate dose(MTD) — Approximately within 36 months
  • Recommended Dose for Expansion — Approximately within 36 months
  • Objective Response Rate (ORR) — Approximately within 36 months
    ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07208773 on ClinicalTrials.gov ↗ ← All trials in China