A Study of YL242 in Subjects With Advanced Solid Tumors

NCT07197827 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YL242-INT-101-01
• Study Type: interventional
• Target: 424
• Locations: 3 countries
• Sites: 15

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Approximately within 36 months

• 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.

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

Secondary Outcomes (6)

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

  Approximately within 36 months

• Maximum Plasma Concentration (Cmax) of YL242

  Approximately within 36 months

• Time to Maximum Plasma Concentration (Tmax) of YL242

  Approximately within 36 months

• Incidence of anti-YL242 antibody

  Approximately within 36 months

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

  Approximately within 36 months

Study Arms (4)

Part 1 and Part 2: Mono Dose Escalation & Expansion

EXPERIMENTAL

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

Drug: YL242

Part 3 and 4: Combination Dose Escalation & Expansion

EXPERIMENTAL

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.

Drug: YL242; Pembrolizumab

Part 5: Combination Dose Optimization and Expansion

EXPERIMENTAL

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

Drug: YL242; 5-FU; LV

Part 6: Combination Dose Optimization and Expansion

EXPERIMENTAL

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

Drug: YL242; Pembrolizumab; 5-FU

Interventions

YL242 DRUG

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.

Part 1 and Part 2: Mono Dose Escalation & Expansion

YL242; Pembrolizumab DRUG

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.

Part 3 and 4: Combination Dose Escalation & Expansion

YL242; 5-FU; LV DRUG

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.

Part 5: Combination Dose Optimization and Expansion

YL242; Pembrolizumab; 5-FU DRUG

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.

Part 6: Combination Dose Optimization and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (15)

US-201

New Haven, Connecticut, 06519, United States

NOT YET RECRUITING

US-202

Sarasota, Florida, 34232, United States

RECRUITING

US-204

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

US-206

Grand Rapids, Michigan, 49546, United States

RECRUITING

US-205

Nashville, Tennessee, 37203, United States

RECRUITING

US-203

Houston, Texas, 77030, United States

NOT YET RECRUITING

US-207

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

AUS-101

Liverpool, New South Wales, 2170, Australia

NOT YET RECRUITING

AUS-102

Darlinghurst, Victoria, 2010, Australia

RECRUITING

AUS-104

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

AUS-103

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

AUS-105

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

CN-303

Harbin, Heilongjiang, 150081, China

RECRUITING

CN-301

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

CN-302

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab; Fluorouracil

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Medilink Study Team

CONTACT

+86 0512-62858368; clinicaltrials@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 26, 2025
• First Posted: September 29, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (7); AU (5); CN (3)