Combination of YL201 and ivonescimab (AK112) for 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

This trial will test whether combining YL201 and ivonescimab (AK112) helps people with advanced solid tumors, including non‑small cell and small cell lung cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. (industry)
• Drugs / interventions: CAR-T, Ivonescimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07208773 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with advanced solid tumors — phase 1 open to a broad advanced‑solid‑tumor population and phase 2 focused on extensive‑stage SCLC and specific NSCLC groups (including EGFR‑mutant) — with ECOG 0–1 and adequate organ function are the intended candidates.

Not a fit: Patients who are eligible for curative local therapy, who have previously received B7‑H3 targeted agents or topoisomerase I–containing ADCs, who experienced grade ≥3 immune‑related adverse events on prior checkpoint inhibitors, or who have significant bleeding/coagulation disorders are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could offer a new treatment option that improves tumor control or prolongs survival for patients with advanced lung and other solid tumors.

How similar studies have performed: Both PD‑(L)1/VEGF bispecific antibodies and antibody–drug conjugates have shown activity in other trials, but combining these two approaches is experimental and not yet proven.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: MediLink Threrapeutics

Conditions: Advanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Advanced solid tumors, PD1/VEGF Bispecific, Antibody drug conjugate