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A Study of YL201 in Patients 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 phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF

Aged ≥18 years

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

Adequate organ and bone marrow function

Disqualifiers

Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study

Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil [eg, tegafur and capecitabine] or small molecular-targeted therapy within 2 weeks or 5 half-life periods [whichever is shorter]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators [eg, thymosin, interferon, and interleukin] within 2 weeks before the first dose).

Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks)

Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study

Trial design

Design model

Sequential

Treatments tested in this trial

  • YL201

    Drug

    Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.

  • YL201

    Drug

    Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.

  • YL201 and atezolizumab

    Drug

    Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle

Treatment groups

312 Participants
are divided into 3 treatment groups
Group A: Dose escalationExperimental treatment 1 intervention
Group B: Dose expansionExperimental treatment 1 intervention
Group C: Dose SelectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the occurrence of DLTs during the first cycle in Part 1

Time frame
21 days of Cycle 1
2

Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

Time frame
By the global end of trial date, approximately within 36 months
3

Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2

PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline

Time frame
Approximately within 36 months
4

Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1

ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

Time frame
Approximately within 36 months

Secondary outcomes

1

Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

Time frame
By the global end of trial date, approximately within 36 months
2

Characterize the PK parameter AUC

Time frame
Approximately within 36 months
3

Characterize the PK parameter Cmax

Time frame
Approximately within 36 months
4

Characterize the PK parameter Ctrough

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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