A Study of YL242 in Subjects With Advanced Solid Tumors

MediLink Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: YL242; Pembrolizumab; 5-FU; Drug: YL242; 5-FU; LV; Drug: YL242; Drug: YL242; Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07197827

YL242-INT-101-01

Details and patient eligibility

About

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.

Enrollment: 424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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424 participants in 4 patient groups

Part 1 and Part 2: Mono Dose Escalation & Expansion

Experimental group

Description:

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

Treatment:

Drug: YL242

Part 3 and 4: Combination Dose Escalation & Expansion

Experimental group

Description:

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.

Treatment:

Drug: YL242; Pembrolizumab

Part 5: Combination Dose Optimization and Expansion

Experimental group

Description:

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

Treatment:

Drug: YL242; 5-FU; LV

Part 6: Combination Dose Optimization and Expansion

Experimental group

Description:

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

Treatment:

Drug: YL242; Pembrolizumab; 5-FU