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

ConditionsAdvanced Solid Tumors Non Small Cell Lung Cancer Small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Suitable for local curative treatment.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

YL201
Drug
YL201 will be administered as IV infusion
Ivonescimab
Drug
Ivonescimab will be administered as IV infusion.

Treatment groups

260 Participants

are divided into 2 treatment groups

Group A: Phase 1： Safety run-inExperimental treatment 2 interventions

Group B: Phase 2： Dose expansionExperimental treatment 2 interventions

Trial outcomes