Recruiting
Phase 1
Phase 2

YL242

Sponsor:

MediLink Therapeutics (Suzhou) Co., Ltd.

Code:

NCT07197827

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

YL242

YL242; Pembrolizumab

YL242; 5-FU; LV

YL242; Pembrolizumab; 5-FU

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Study ID

NCT07197827

Start date

Sep 22, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

424 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 and Part 2: Mono Dose Escalation & Expansion

Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.

experimental: Part 3 and 4: Combination Dose Escalation & Expansion

Participants 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.

experimental: Part 5: Combination Dose Optimization and Expansion

Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.

experimental: Part 6: Combination Dose Optimization and Expansion

Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.

Interventions

YL242

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; Pembrolizumab

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; LV

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-FU

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.

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 ]
  • Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 42 days post last patients last dose, approximately within 36 months ]

Central Contacts and Locations

Central contacts

Locations

US-202

Recruiting

Sarasota, Florida, United States, 34232

US-206

Recruiting

Grand Rapids, Michigan, United States, 49546

US-205

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Oncology
  • VEGF
  • Antibody drug conjugate
  • Developmental Phase I/II

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MediLink Therapeutics (Suzhou) Co., Ltd. on 2025-12-24.