A Clinical Study of YL205 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
About this trial
This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).
Disqualifiers
1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
Trial design
Design model
Sequential
Treatments tested in this trial
intravenous (IV) infusion
DrugYL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Treatment groups
252 Participants
are divided into 3 treatment groupsGroup A: Phase Ia: Dose escalation portionExperimental treatment 1 intervention
Group B: Phase Ib: Dose expansion portionExperimental treatment 1 intervention
Group C: Phase II: Cohort expansion portionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evalue the DLTs
Time frame
Approximately within 36 months2
To evalue the TEAEs
Treatment Emergent Adverse Event
Time frame
Approximately within 36 months3
To evalue the TRAEs
Treatment Related Adverse Event
Time frame
Approximately within 36 months4
To evalue the serious adverse events (SAEs)
Time frame
Approximately within 36 monthsSecondary outcomes
1
Characterize the PK parameter AUC
area under curve (AUC)
Time frame
Approximately within 36 months2
Characterize the PK parameter Cmax
maximum concentration (Cmax)
Time frame
Approximately within 36 months3
Characterize the PK parameter Ctrough
minimum concentration at trough (Ctrough)
Time frame
Approximately within 36 months4
Characterize the PK parameter Vd
volume of distribution (Vd)
Time frame
Approximately within 36 monthsSponsors and contacts
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Source ClinicalTrials.gov