Combination of YL201 and ivonescimab (AK112) for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial combines YL201, an antibody–drug conjugate, with ivonescimab (AK112), a PD‑1/VEGF bispecific antibody, to treat patients with advanced solid tumors including non‑small cell and small cell lung cancer. Phase 1 will emphasize safety, tolerability and dose finding, while phase 2 will expand into disease‑specific cohorts such as extensive‑stage SCLC and NSCLC subgroups including EGFR‑mutant patients. Eligible participants are adults with ECOG performance status 0–1 and adequate organ and marrow function, and several prior therapies (for example B7‑H3 targeted agents or topoisomerase I–containing ADCs) are exclusionary. The trial is sponsored by MediLink Therapeutics in collaboration with Akesobio and is conducted at Sun Yat‑sen University Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: MediLink Threrapeutics
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 512 62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.