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RecruitingNCT07208773Updated Jun 18, 2026

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

A Phase 1/2 interventional study of YL201 and Ivonescimab in Advanced Solid Tumors, Non Small Cell Lung Cancer and Small Cell Lung Cancer, sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
260
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • Advanced solid tumors
  • PD1/VEGF Bispecific
  • Antibody drug conjugate
  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 260 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

MediLink Therapeutics (Suzhou) Co., Ltd. is the lead sponsor of 23 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: YL201 · Drug: Ivonescimab

  • Experimental
    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.

    Drug: YL201 · Drug: Ivonescimab

Interventions

  • DrugYL201

    YL201 will be administered as IV infusion

  • DrugIvonescimab

    Ivonescimab will be administered as IV infusion.

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    AEs are assessed based on NCI CTCAE v5.0.

    Time frame: Approximately within 36 months

  2. Maximum tolerate dose（MTD)

    Time frame: Approximately within 36 months

  3. Recommended Dose for Expansion

    Time frame: Approximately within 36 months

  4. 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).

    Time frame: Approximately within 36 months

Secondary outcomes

  1. Area Under the Concentration-time Curve (AUC)

    Time frame: Approximately within 36 months

  2. maximum concentration (Cmax)

    Time frame: Approximately within 36 months

  3. minimum concentration at trough (Ctrough)

    Time frame: Approximately within 36 months

  4. Volume of distribution (Vd)

    Time frame: Approximately within 36 months

  5. plasma clearance (CL)

    Time frame: Approximately within 36 months

  6. half-life (t1/2)

    Time frame: Approximately within 36 months

  7. Time to peak drug concentration (Tmax)

    Time frame: Approximately within 36 months

  8. Investigator-assessed progression-free survival (PFS)

    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

    Time frame: Approximately within 36 months

  9. Investigator-assessed overall survival (OS)

    OS defined as the time interval from the first study drug administration to death due to any cause.

    Time frame: Approximately within 36 months

  10. Investigator-assessed disease control rate (DCR)

    DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).

    Time frame: Approximately within 36 months

  11. Investigator-assessed time to response (TTR)

    TTR defined as the time interval from the first study drug administration to the first documentation of response (CR or PR).

    Time frame: Approximately within 36 months

  12. Investigator-assessed the depth of response (DpR) per RECIST v1.1

    The percentage change in target lesion size

    Time frame: Approximately within 36 months

  13. number of subjects who are Anti-Drug Antibody (ADA)-positive at any time

    Time frame: Approximately within 36 months

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    • Study Coordinator · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07208773
Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Collaborators
Akesobio
Responsible party
Sponsor
First posted
Oct 6, 2025
Start date
Oct 29, 2025
Primary completion
Jan 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

MediLink Threrapeutics
Contact
clinicaltrials@medilinkthera.com
+86 512 62858368

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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