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 volunteersQualifiers
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
Single group
Treatments tested in this trial
YL217
DrugPatients will be treated with YL217 intravenous(IV)infusion.
YL217
DrugPatients will be treated with YL217 intravenous(IV)infusion.
YL217
DrugPatients will be treated with YL217 intravenous(IV)infusion.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Part 2: The backfill stage of YL217Experimental treatment 1 intervention
Group B: Part 1: Dose-Escalation PartExperimental treatment 1 intervention
Group C: Part 3: Dose-Expansion PartExperimental 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 years2
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 years3
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 yearsSecondary 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 years2
To evaluate safety endpoint of peripheral oxygen saturation (SpO2)
Time frame
Up to approximately 3 years3
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 years4
Characterize Pharmacokinetics(PK) parameter Cmax
Maximum concentration：The highest measured concentration of YL217 in the bloodstream.
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov