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Advanced Solid TumorsPhase 1/2NCT07208773

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

A Phase 1/2 study testing YL201 and Ivonescimab in people with Advanced Solid Tumors and Non Small Cell Lung Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
YL201 and Ivonescimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
29 Oct 2025to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MediLink Threrapeutics contact

+86 512 62858368

clinicaltrials@medilinkthera.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Study Coordinator

    Recruiting

Other trials in China

About this study

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

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

Being tested
YL201, Ivonescimab
Keywords
Advanced solid tumors, PD1/VEGF Bispecific, Antibody drug conjugate, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL201Drug

    YL201 will be administered as IV infusion

  • IvonescimabDrug

    Ivonescimab will be administered as IV infusion.

Study groups in NCT07208773
Study groupRoleWhat they receive
Phase 1： Safety run-inExperimentalMultiple 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.
Receives: Drug: YL201; Drug: Ivonescimab
Phase 2： Dose expansionExperimentalYL201 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.
Receives: Drug: YL201; Drug: Ivonescimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events (AEs)

    AEs are assessed based on NCI CTCAE v5.0.

    Measured: Approximately within 36 months

  2. Maximum tolerate dose（MTD)

    Measured: Approximately within 36 months

  3. Recommended Dose for Expansion

    Measured: 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).

    Measured: Approximately within 36 months

Secondary outcomes (13)

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

    Measured: Approximately within 36 months

  2. maximum concentration (Cmax)

    Measured: Approximately within 36 months

  3. minimum concentration at trough (Ctrough)

    Measured: Approximately within 36 months

  4. Volume of distribution (Vd)

    Measured: Approximately within 36 months

  5. plasma clearance (CL)

    Measured: Approximately within 36 months

  6. half-life (t1/2)

    Measured: Approximately within 36 months

  7. Time to peak drug concentration (Tmax)

    Measured: 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

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: Approximately within 36 months

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

    The percentage change in target lesion size

    Measured: Approximately within 36 months

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

    Measured: Approximately within 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start29 Oct 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07208773
Sponsor's protocol ID
YL201-CN-104-02
Status last verified
Nov 2025
First submitted
28 Sep 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL201 and Ivonescimab in people with Advanced Solid Tumors and Non Small Cell Lung Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MediLink Threrapeutics (+86 512 62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: Approximately within 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07208773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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