TRK-950 for advanced solid tumors and melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Toray Contact for Clinical Trial Information
• Email: npdd-clinical.toray.mb@mail.toray
• Phone: +81467-32-9948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.