TRK-950 for advanced solid tumors and melanoma
A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
This trial tests whether TRK-950, alone or with the immunotherapy nivolumab, is safe in adults with advanced solid tumors or in people with unresectable or metastatic melanoma who have had prior chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Toray Industries, Inc Industry-sponsored |
| Drugs / interventions | chemotherapy, nivolumab |
| Locations | 10 sites (Nagoya, Aichi-ken and 9 other locations) |
| Trial ID | NCT05423262 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1/2 trial has three parts to define safety, tolerability, pharmacokinetics, and immune responses to TRK-950. Part 1 gives two dose levels of TRK-950 alone to adults with locally advanced or metastatic solid tumors who are refractory or intolerant to standard therapies. Part 2 gives two dose levels of TRK-950 combined with standard-dose nivolumab in patients eligible for nivolumab therapy. Part 3 administers a single dose level of TRK-950 to patients with unresectable or metastatic melanoma previously treated with dacarbazine to gather preliminary efficacy and safety data.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed locally advanced or metastatic solid tumors refractory or intolerant to standard therapies, or adults with unresectable/metastatic melanoma previously treated with dacarbazine and, for the combination arm, eligible for nivolumab.
Not a fit: Patients unlikely to benefit include those with uveal melanoma (excluded), those with life expectancy under three months, pregnant people, or individuals who cannot receive nivolumab when required by the combination arm.
Why it matters
Potential benefit: If successful, TRK-950 could provide a new treatment option for patients with advanced solid tumors or for those with unresectable melanoma who have exhausted standard therapies.
How similar studies have performed: Combinations with nivolumab and other novel agents have shown benefit in some cancers, but TRK-950 itself is novel and its safety and efficacy in humans remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Patients who are able to provide written consent in person to be a subject of this study * A negative pregnancy test before enrollment (if female of childbearing potential) Exclusion Criteria: * 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 * Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing * Patients who are positive for hepatitis B surface antigen (HBsAg) * Patients who are positive for HCV RNA
Where this trial is running
Nagoya, Aichi-ken and 9 other locations
- Nagoya City University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
- National Hospital Organization Kyushu Cancer Center — Fukuoka, Fukuoka, Japan (Recruiting)
- Sapporo Medical University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
- Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (Recruiting)
- Shinshu University Hospital — Matsumoto, Nagano, Japan (Recruiting)
- Niigata Cancer Center Hospital — Niigata, Niigata, Japan (Recruiting)
- Saitama Medical University International Medical Center — Hidaka, Saitama, Japan (Recruiting)
- Shizuoka Cancer Center — Nagaizumi-chō, Shizuoka, Japan (Recruiting)
- National Cancer Center Hospital — Chuo Ku, Tokyo, Japan (Recruiting)
- Keio University Hospital — Shinjuku-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Toray Contact for Clinical Trial Information
- Email: npdd-clinical.toray.mb@mail.toray
- Phone: +81467-32-9948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.