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Recruiting NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YL242, YL242; Pembrolizumab, YL242; 5-FU; LV, YL242; Pembrolizumab; 5-FU.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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 measures

  • 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]
Secondary outcome measures (6)
  • Area Under the Serum Concentration Time Curve (AUC) of YL242 [Time frame: Approximately within 36 months]
  • Maximum Plasma Concentration (Cmax) of YL242 [Time frame: Approximately within 36 months]
  • Time to Maximum Plasma Concentration (Tmax) of YL242 [Time frame: Approximately within 36 months]
  • Incidence of anti-YL242 antibody [Time frame: Approximately within 36 months]
  • Terminal Elimination Half-life (t1/2) of Serum YL242 [Time frame: Approximately within 36 months]
  • Disease Control Rate (DCR) [Time frame: Approximately within 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • US-201 — New Haven
  • US-202 — Sarasota
  • US-204 — Boston
  • US-206 — Grand Rapids
  • US-205 — Nashville
  • US-203 — Houston
  • US-207 — San Antonio
Australia · 5 centers
  • AUS-101 — Liverpool
  • AUS-102 — Darlinghurst
  • AUS-104 — Fitzroy
  • AUS-103 — Heidelberg
  • AUS-105 — Nedlands
China · 3 centers
  • CN-303 — Harbin
  • CN-301 — Shanghai
  • CN-302 — Hangzhou

Identifiers

NCT: NCT07197827 · YL242-INT-101-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗