Health TrialsbyHealthPanel

A Study of YL202 in Selected Patients With Advanced Solid Tumors

ConditionsNSCLCBreast CancerHNSCCLocally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).

Subjects aged from 18-75 (inclusive) years.

Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..

At least one extracranial measurable lesion according to RECIST 1.1.

Disqualifiers

With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).

Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.

Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.

The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.

Trial design

Design model

Single group

Treatments tested in this trial

  • YL202 should be intravenously infused

    Drug

    For each patient, YL202 should be intravenously infused over 60±10 min.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Corhort AExperimental treatment 1 intervention
Group B: Corhort BExperimental treatment 1 intervention
Group C: Corhort CExperimental treatment 1 intervention
Group D: Corhort DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR assessed according to RECIST v1.1

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

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

Determination of the recommended dose of YL202 in the pivotal clinical study

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

Secondary outcomes

1

Progression-free survival (PFS) assessed according to RECIST v1.1

Time frame
approximately within 36 months
2

Clinical benefit rate (CBR) assessed according to RECIST v1.1

Time frame
approximately within 36 months
3

depth of response (DpR) assessed according to RECIST v1.1

Time frame
Approximately within 36 months
4

disease control rate (DCR) assessed according to RECIST v1.1

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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