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Recruiting NCT07208773

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

Phase I / Phase II Interventional Advanced Solid Tumors Non Small Cell Lung Cancer Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YL201, Ivonescimab.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

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

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Approximately within 36 months]
  • Maximum tolerate dose（MTD) [Time frame: Approximately within 36 months]
  • Recommended Dose for Expansion [Time frame: Approximately within 36 months]
  • Objective Response Rate (ORR) [Time frame: Approximately within 36 months]
Secondary outcome measures (12)
  • Area Under the Concentration-time Curve (AUC) [Time frame: Approximately within 36 months]
  • maximum concentration (Cmax) [Time frame: Approximately within 36 months]
  • minimum concentration at trough (Ctrough) [Time frame: Approximately within 36 months]
  • Volume of distribution (Vd) [Time frame: Approximately within 36 months]
  • plasma clearance (CL) [Time frame: Approximately within 36 months]
  • half-life (t1/2) [Time frame: Approximately within 36 months]
  • Time to peak drug concentration (Tmax) [Time frame: Approximately within 36 months]
  • Investigator-assessed progression-free survival (PFS) [Time frame: Approximately within 36 months]
  • Investigator-assessed overall survival (OS) [Time frame: Approximately within 36 months]
  • Investigator-assessed disease control rate (DCR) [Time frame: Approximately within 36 months]
  • Investigator-assessed time to response (TTR) [Time frame: Approximately within 36 months]
  • Investigator-assessed the depth of response (DpR) per RECIST v1.1 [Time frame: Approximately within 36 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization.
  • Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels.
  • Active autoimmune disease requiring systemic treatment.
  • Brain metastases or spinal cord compression.
  • Patients with uncontrolled or clinically significant cardiovascular diseases.
  • Clinically significant concurrent pulmonary diseases.
  • Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/ exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07208773 · YL201-CN-104-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗