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

MediLink Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer; Advanced Solid Tumors; Non Small Cell Lung Cancer

Treatments: Drug: YL201; Drug: Ivonescimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07208773

YL201-CN-104-02

Details and patient eligibility

About

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

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Phase 1： Safety run-in

Experimental group

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.

Treatment:

Drug: Ivonescimab

Drug: YL201

Phase 2： Dose expansion

Experimental group

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.

Treatment:

Drug: Ivonescimab

Drug: YL201