A Study of TRK-950 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorToray Industries, Inc
About this trial
Part 1
• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors
Part 2
• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy
Part 3
• To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists
Patients with life expectancy of at least 3 months after the start of study drug administration
Patients aged >=18 years at the time of consent
Disqualifiers
Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
Patients who are unwilling or unable to comply with the protocol specified procedures
Patients who are positive for human immunodeficiency virus (HIV) antibody
Trial design
Design model
Single group
Treatments tested in this trial
TRK-950
Biological/Vaccine5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950
Biological/Vaccine10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950
Biological/Vaccine20 mg/kg administered intravenously over 60 minutes (bi-weekly)
Nivolumab
Drug240 mg administered intravenously over 30 minutes (bi-weekly)
TRK-950
Biological/Vaccine10 mg/kg administered Intravenously over 60 minutes (weekly)
Treatment groups
49 Participants
are divided into 4 treatment groupsGroup A: Part 1 : TRK-950Experimental treatment 1 intervention
Group B: Part 2 Cohort 1: TRK-950+NivolumabExperimental treatment 2 interventions
Group C: Part 2 Cohort 2: TRK-950+NivolumabExperimental treatment 2 interventions
Group D: Part 3: TRK-950Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
Number of participants with DLTs will be determined.
Time frame
Up to Day 282
Number of participants with adverse events (AEs) (Part 1 and 2)
Number of participants with AEs will be assessed.
Time frame
through study completion, an average of 1 year3
Number of participants with adverse events of special interest (AESIs) (Part 1 and 2)
Number of participants with AESIs will be assessed.
Time frame
through study completion, an average of 1 year4
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
Number of participants with SAEs will be assessed.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)
Time frame
through study completion, an average of 1 year2
Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)
Time frame
through study completion, an average of 1 year3
Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)
Time frame
through study completion, an average of 1 year4
Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov