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A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

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

About this trial

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed of the study before the start of the study and voluntarily sign their name and date in the ICF

Able and willing to comply with protocol visits and procedures

Age≥ 18 years

ECOG PS of 0 or 1

Disqualifiers

Prior treatment with an agent targeting CDH17

Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.

Have received an ADC consisting of a topoisomerase I inhibitor.

Concurrent enrollment in another clinical study, unless it is an observational clinical study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • YL217

    Drug

    Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

  • Bevacizumab

    Drug

    Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.

  • 5-FU with leucovorin

    Drug

    Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: Combo-Dose Escalation,Backfill and ExpansionExperimental treatment 3 interventions
Group B: Mono-Dose Escalation,Backfill and ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Nature and frequency of dose-limiting toxicity(DLT)

The purpose of DLT is to find maximum tolerated dose (MTD).

Time frame
Up to approximately 3 years
2

Nature and frequency of adverse events (AEs) with severity

Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.

Time frame
Up to approximately 3 years
3

objective response rate (ORR)

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

Time frame
Up to approximately 3 years

Secondary outcomes

1

Eastern Cooperative Oncology Group performance status (ECOG PS)

Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)

Time frame
Up to approximately 3 years
2

To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

Time frame
Up to approximately 3 years
3

Characterize Pharmacokinetics(PK) parameter AUC

The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.

Time frame
Up to approximately 3 years
4

Characterize Pharmacokinetics(PK) parameter Cmax

Maximum concentration：The highest measured concentration of YL217 in the bloodstream.

Time frame
Up to approximately 3 years

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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