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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05423262
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Toray Industries, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Solid Tumor, Melanoma

Additional Details

This is an open-label phase I/II study and consists of three parts. In 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 will receive two dose level of TRK-950. In 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 will receive two dose level of TRK-950 in combination with Nivolumab. In 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 will receive one dose level of TRK-950. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.

Arms & Interventions

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.

Interventions

Biological: - TRK-950

5 or 10 mg/kg administered intravenously over 60 minutes (weekly)

Biological: - TRK-950

10 mg/kg administered intravenously over 60 minutes (weekly)

Biological: - TRK-950

20 mg/kg administered intravenously over 60 minutes (bi-weekly)

Drug: - Nivolumab

240 mg administered intravenously over 30 minutes (bi-weekly)

Biological: - TRK-950

10 mg/kg administered Intravenously over 60 minutes (weekly)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Cancer Center Hospital, Chuo Ku, Tokyo 1850144, Japan

Status

Address

National Cancer Center Hospital

Chuo Ku, Tokyo 1850144,

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