Health TrialsbyHealthPanel

A Study of YL242 in Subjects With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years.

Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

Adequate organ and bone marrow function

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

424 Participants
are divided into 4 treatment groups
Group A: Part 1 and Part 2: Mono Dose Escalation & ExpansionExperimental treatment 1 intervention
Group B: Part 3 and 4: Combination Dose Escalation & ExpansionExperimental treatment 1 intervention
Group C: Part 5: Combination Dose Optimization and ExpansionExperimental treatment 1 intervention
Group D: Part 6: Combination Dose Optimization and ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

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

Secondary outcomes

1

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

Time frame
Approximately within 36 months
2

Maximum Plasma Concentration (Cmax) of YL242

Time frame
Approximately within 36 months
3

Time to Maximum Plasma Concentration (Tmax) of YL242

Time frame
Approximately within 36 months
4

Incidence of anti-YL242 antibody

Time frame
Approximately within 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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