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Taking people in ChinaPhase 1/2

Tests YL201 with ivonescimab in advanced solid tumors and lung cancer

Tests YL201 combined with ivonescimab in adults with advanced solid tumors or lung cancer.

Key facts

Who runs it
MediLink Therapeutics (Suzhou) Co., Ltd.
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
260 people, planned
Started
29 Oct 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • YL201
  • Ivonescimab
Record updated
18 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors. Phase 2 looks at extensive-stage small cell lung cancer and non-small cell lung cancer, including EGFR-mutated disease.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Phase 1: advanced solid tumors. Phase 2: extensive-stage small cell lung cancer, non-small cell lung cancer without common gene changes (non-AGA), or EGFR-mutated non-small cell lung cancer.
Earlier treatment
People who have had drugs aimed at B7-H3, or topoisomerase I inhibitors (including antibody-drug conjugates with them), cannot join.
Biomarker or test result
EGFR mutation for the EGFR-mutated lung cancer group; non-AGA for the other non-small cell lung cancer group.

Main reasons for not taking part

  • Local treatment meant to remove all of the disease is possible
  • Serious immune side effects (grade 3 or higher) from earlier immunotherapy
  • Brain metastases or spinal cord compression
  • Active autoimmune disease needing treatment throughout the body
  • Bleeding or clotting disorders, or serious heart, lung or active tuberculosis disease

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age ≥ 18 years old
  • Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC
  • ECOG PS score is 0 or 1
  • Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements

Who cannot take part

  • Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs)
  • Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors
  • Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) [anti-PD-(L)1] or other immune checkpoint inhibitors
  • History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization
  • Clinically significant concurrent pulmonary diseases
  • Active autoimmune disease requiring systemic treatment
  • Patients with uncontrolled or clinically significant cardiovascular diseases
  • Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/ exclusion criteria may apply
  • Suitable for local curative treatment
  • Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels
  • Brain metastases or spinal cord compression

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Phase 1： Safety run-inTreatment being tested

    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.

    Treatment: YL201 and Ivonescimab

  • Phase 2： Dose expansionTreatment being tested

    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.

    Treatment: YL201 and Ivonescimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests YL201 with ivonescimab in advanced solid tumors and lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 June 2026