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

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors; Non Small Cell Lung Cancer; Small Cell Lung Cancer
• Interventions: Drug: YL201; Drug: Ivonescimab

• Registration Number: NCT07208773
• Lead Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-28
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study Start: 2025-10-01
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2027-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1： Safety run-in	YL201	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.
Phase 1： Safety run-in	Ivonescimab	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.
Phase 2： Dose expansion	YL201	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.
Phase 2： Dose expansion	Ivonescimab	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	Approximately within 36 months	AEs are assessed based on NCI CTCAE v5.0.
Maximum tolerate dose（MTD)	Approximately within 36 months
Recommended Dose for Expansion	Approximately within 36 months
Objective Response Rate (ORR)	Approximately within 36 months	ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve (AUC)	Approximately within 36 months
maximum concentration (Cmax)	Approximately within 36 months
minimum concentration at trough (Ctrough)	Approximately within 36 months
Volume of distribution (Vd)	Approximately within 36 months
plasma clearance (CL)	Approximately within 36 months
half-life (t1/2)	Approximately within 36 months
Time to peak drug concentration (Tmax)	Approximately within 36 months
Investigator-assessed progression-free survival (PFS)	Approximately within 36 months	PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first
Investigator-assessed overall survival (OS)	Approximately within 36 months	OS defined as the time interval from the first study drug administration to death due to any cause.
Investigator-assessed disease control rate (DCR)	Approximately within 36 months	DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Investigator-assessed time to response (TTR)	Approximately within 36 months	TTR defined as the time interval from the first study drug administration to the first documentation of response (CR or PR).
Investigator-assessed the depth of response (DpR) per RECIST v1.1	Approximately within 36 months	The percentage change in target lesion size
number of subjects who are Anti-Drug Antibody (ADA)-positive at any time	Approximately within 36 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China