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

NCT ID: NCT07208773

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-29
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1： Safety run-in

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.

Group Type: EXPERIMENTAL

YL201

Intervention Type: DRUG

YL201 will be administered as IV infusion

Ivonescimab

Intervention Type: DRUG

Ivonescimab will be administered as IV infusion.

Phase 2： Dose expansion

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.

Group Type: EXPERIMENTAL

YL201

Intervention Type: DRUG

YL201 will be administered as IV infusion

Ivonescimab

Intervention Type: DRUG

Ivonescimab will be administered as IV infusion.

Interventions

YL201

YL201 will be administered as IV infusion

Intervention Type: DRUG

Ivonescimab

Ivonescimab will be administered as IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akesobio

INDUSTRY

Sponsor Role: collaborator

MediLink Therapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

MediLink Threrapeutics

Role: CONTACT

clinicaltrials@medilinkthera.com

+86 512 62858368

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

YL201-CN-104-02

Identifier Type: -

Identifier Source: org_study_id