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

Qualifiers

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

Treatments tested in this trial

  • TRK-950
  • TRK-950
  • TRK-950
  • Nivolumab
  • TRK-950

Treatment groups

49 Participants
are divided into 4 treatment groups

Sponsors and collaborators