NCT07208773

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

October 29, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

September 28, 2025

Last Update Submit

November 14, 2025

Conditions

Advanced Solid TumorsNon Small Cell Lung CancerSmall Cell Lung Cancer

Keywords

Advanced solid tumorsPD1/VEGF BispecificAntibody drug conjugateNon Small Cell Lung CancerSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

  • Incidence and severity of adverse events (AEs)

    AEs are assessed based on NCI CTCAE v5.0.

    Approximately within 36 months

  • Maximum tolerate dose（MTD)

    Approximately within 36 months

  • Recommended Dose for Expansion

    Approximately within 36 months

  • Objective Response Rate (ORR)

    ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).

    Approximately within 36 months

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Phase 1： Safety run-in

EXPERIMENTAL

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.

Drug: YL201Drug: Ivonescimab

Phase 2： Dose expansion

EXPERIMENTAL

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.

Drug: YL201Drug: Ivonescimab

Interventions

YL201DRUG

YL201 will be administered as IV infusion

Phase 1： Safety run-inPhase 2： Dose expansion
IvonescimabDRUG

Ivonescimab will be administered as IV infusion.

Phase 1： Safety run-inPhase 2： Dose expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

MediLink Threrapeutics

CONTACT

+86 512 62858368clinicaltrials@medilinkthera.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start

October 29, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

CN(1)