A Study of TRK-950 in Patients With Advanced Solid Tumors

Sponsor
Toray Industries, Inc
Study ID
NCT05423262
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TRK-950 — BIOLOGICAL
    5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
  • TRK-950 — BIOLOGICAL
    10 mg/kg administered intravenously over 60 minutes (weekly)
  • TRK-950 — BIOLOGICAL
    20 mg/kg administered intravenously over 60 minutes (bi-weekly)
  • Nivolumab — DRUG
    240 mg administered intravenously over 30 minutes (bi-weekly)
  • TRK-950 — BIOLOGICAL
    10 mg/kg administered Intravenously over 60 minutes (weekly)

Study Details

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

Key Dates

Start date
Jul 6, 2022
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 : TRK-950
    * Solid Tumor * TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. Two dose levels will be explored during this Arm.
  • Experimental: Part 2 Cohort 1: TRK-950+Nivolumab
    * Nivolumab-eligible solid tumor * Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
  • Experimental: Part 2 Cohort 2: TRK-950+Nivolumab
    * Nivolumab-eligible solid tumor * Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
  • Experimental: Part 3: TRK-950
    * Melanoma * TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2) [ Time Frame: Up to Day 28 ]

Central Contacts

Related Studies