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Advanced Solid TumorPhase 1/2NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing YL242, YL242; Pembrolizumab and YL242; 5-FU; LV in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 15 sites in 3 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YL242, YL242; Pembrolizumab and YL242; 5-FU; LV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
15 sitesin 3 countries
Study dates
22 Sep 2025to Nov 2028
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

  • Aged ≥18 years.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Adequate organ and bone marrow function
  • Tumor type:
  • Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy
  • Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;
  • Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy
  • Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy

Who cannot join

  • Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
  • Clinically significant concomitant pulmonary disease
  • A history of leptomeningeal carcinomatosis or carcinomatous meningitis
  • Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

Trial locations and contacts

15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Medilink Study Team contact

+86 0512-62858368

clinicaltrials@medilinkthera.com

15 sites in 3 countries

United States7 sites, 7 recruiting

  • US-204

    Boston, Massachusetts, 02215

    study coordinator

    Not yet recruiting

  • US-206

    Grand Rapids, Michigan, 49546

    study coordinator

    Recruiting

  • US-203

    Houston, Texas, 77030

    study coordinator

    Not yet recruiting

  • US-205

    Nashville, Tennessee, 37203

    study coordinator

    Recruiting

  • US-201

    New Haven, Connecticut, 06519

    study coordinator

    Not yet recruiting

  • US-207

    San Antonio, Texas, 78229

    study coordinator

    Not yet recruiting

  • US-202

    Sarasota, Florida, 34232

    study coordinator

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • AUS-102

    Darlinghurst, Victoria, 2010

    study coordinator

    Recruiting

  • AUS-104

    Fitzroy, Victoria, 3065

    study coordinator

    Not yet recruiting

  • AUS-103

    Heidelberg, Victoria, 3084

    study coordinator

    Not yet recruiting

  • AUS-101

    Liverpool, New South Wales, 2170

    study coordinator

    Not yet recruiting

  • AUS-105

    Nedlands, Western Australia, 6009

    study coordinator

    Not yet recruiting

Other trials in Australia

China3 sites, 3 recruiting

  • CN-302

    Hangzhou, Zhejiang, 310022

    study coordinator

    Recruiting

  • CN-303

    Harbin, Heilongjiang, 150081

    study coordinator

    Recruiting

  • CN-301

    Shanghai, Shanghai Municipality, 200030

    study coordinator

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.

This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.

Being tested
YL242, YL242; Pembrolizumab, YL242; 5-FU; LV, YL242; Pembrolizumab; 5-FU
Keywords
Oncology, VEGF, Antibody drug conjugate, Developmental Phase I/II
Medical subject headings
Neoplasms

What participants receive

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

  • YL242Drug

    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.

  • YL242; PembrolizumabDrug

    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.

  • YL242; 5-FU; LVDrug

    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.

    LV and 5-FU will be sequentially administered following YL242.

  • YL242; Pembrolizumab; 5-FUDrug

    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion.

    Pembrolizumab and 5-FU will be administered in sequence after YL242.

Study groups in NCT07197827
Study groupRoleWhat they receive
Part 1 and Part 2: Mono Dose Escalation & ExpansionExperimentalParticipants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
Receives: Drug: YL242
Part 3 and 4: Combination Dose Escalation & ExpansionExperimentalParticipants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.
Receives: Drug: YL242; Pembrolizumab
Part 5: Combination Dose Optimization and ExpansionExperimentalParticipants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
Receives: Drug: YL242; 5-FU; LV
Part 6: Combination Dose Optimization and ExpansionExperimentalParticipants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.
Receives: Drug: YL242; Pembrolizumab; 5-FU

What is being measured

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

  1. Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)

    Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Approximately within 36 months

  2. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)

    AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.

    Measured: Baseline up to 42 days post last patients last dose, approximately within 36 months

Secondary outcomes (6)

  1. Area Under the Serum Concentration Time Curve (AUC) of YL242

    Measured: Approximately within 36 months

  2. Maximum Plasma Concentration (Cmax) of YL242

    Measured: Approximately within 36 months

  3. Time to Maximum Plasma Concentration (Tmax) of YL242

    Measured: Approximately within 36 months

  4. Incidence of anti-YL242 antibody

    Measured: Approximately within 36 months

  5. Terminal Elimination Half-life (t1/2) of Serum YL242

    Measured: Approximately within 36 months

  6. Disease Control Rate (DCR)

    Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.

    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 posted29 Sep 2025
  2. Study start22 Sep 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionNov 2028 (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
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07197827
Sponsor's protocol ID
YL242-INT-101-01
Status last verified
Dec 2025
First submitted
26 Sep 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL242, YL242; Pembrolizumab and YL242; 5-FU; LV in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 15 sites in 3 countries.

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 8 inclusion and 5 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Australia, 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 Study Team (+86 0512-62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6) (time frame: Approximately within 36 months). The study lists 2 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 NCT07197827.

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 24 Dec 2025.

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