A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

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A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

Study Purpose

The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel for selected advanced solid tumors.

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:

- Histologically confirmed solid malignancy for which the following treatment regimens are warranted: - Arm A.

Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care.

- Arm B.

Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care.

- Arm C.

Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care.

- Arm D.

Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care.

- Arm E.

Solid Tumors: Eligible for PD1 Inhibitor (Nivolumab or Pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority.

- Arm F.

Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion (≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream (US Sites Only)

- Arm G.

Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment.

- Arm H.

Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1.

- Arm J.

Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1.

- Arm K.

(US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950.

- Arm O.

Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950.

- Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum.

- Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum.

- Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy.

- Arm Q.

Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care.

- Arm R.

Clear cell renal cell carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment.

- Arm S.

Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 182 days after most recent platinum-based chemotherapy and who are eligible for carboplatin, PLD, and bevacizumab as standard of care.

- The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS) - Patients with or without the breast cancer susceptibility 1/2 (BRCA1/2) mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment.

- Arm T.

Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, or as defined below, and who are eligible for paclitaxel as standard of care.

- Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission (CR) or partial response/remission (PR), and then progressed between 90 days to less than 183 days after the last date of platinum.

- Patients who have received multiple lines of platinum therapy must have progressed on the latest platinum, or within 183 days after the date of the last dose of the latest platinum.

- Patients with or without the BRCA1/2 mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment.

- Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy.

- The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS) - Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions) - Karnofsky performance of ≥70.

- Life expectancy of at least 3 months.

- Age ≥ 18 years.

- Signed, written IRB-approved informed consent.

Exclusion Criteria:

- Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens.

- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.

Prophylactic antibiotics are acceptable.

- Pregnant or nursing women.

- Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).

- Unwillingness or inability to comply with procedures required in this protocol.

- Known active infection with HIV, hepatitis B, hepatitis C.

- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.

- Patients who are currently receiving any other investigational agent.

- Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information

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.	NCT03872947
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
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	France, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Solid Tumor, Colorectal Cancer, Cholangiocarcinoma, Bladder Cancer, Ovarian Cancer, Gastric Cancer, Palpable Subcutaneous Malignant Lesions, Renal Cell Carcinoma, Melanoma, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Additional Details

This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab 8) Gemcitabine / Carboplatin / Bevacizumab, 9)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.

Arms & Interventions

Arms

Experimental: Arm A: TRK-950 + FOLFIRI

- Colorectal Cancer - TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.

Experimental: Arm B: TRK-950 + Gemcitabine/Cisplatin

- Cholangiocarcinoma or Bladder Cancer - TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.

Experimental: Arm C: TRK-950 + Gemcitabine/Carboplatin

- Ovarian Cancer - TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.

Experimental: Arm D: TRK-950 + Ramucirumab/Paclitaxel

- Gastric Cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.

Experimental: Arm E: TRK-950 + PD1 inhibitors

•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

Experimental: Arm F: TRK-950 + Imiquimod Cream

- Palpable subcutaneous malignant lesions - TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).

Experimental: Arm G: TRK-950 + Bevacizumab

- Renal Cell Carcinoma - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.

Experimental: Arm H: TRK-950 + PD1 inhibitors

•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

Experimental: Arm J: TRK-950 + FOLFIRI

- Colorectal Cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.

Experimental: Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab

- Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer - TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.

Experimental: Arm O: TRK-950 + PLD

- Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.

Experimental: Arm Q: TRK-950 + Ramucirumab/Paclitaxel

- Gastric cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.

Experimental: Arm R: TRK-950 + Bevacizumab

- Renal cell carcinoma cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.

Experimental: Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab

- Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer - Treatment Phase: TRK-950 will be administered IV on days 1 and 15 of a 28-day cycle. Carboplatin will be administered as an intravenous infusion on day 1. On day 1, following the administration of Carboplatin, PLD will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. On days 1 and 15, TRK-950 will be administered IV after the Bevacizumab infusion. • Maintenance Phase: After 6 cycles of chemotherapy, the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Following the Bevacizumab administration, TRK-950 will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.

Experimental: Arm T: TRK-950 + Paclitaxel

- Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer - TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1, 8 and 15 of each cycle, Paclitaxel will be dosed on IV

Interventions

Biological: - TRK-950

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

Biological: - TRK-950

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

Biological: - TRK-950

Treatment Phase: 20 mg/kg administered intravenously over 60 minutes (bi-weekly) Maintenance Phase: 30 mg/kg administered intravenously over 60 minutes (every 3 weeks)

Drug: - Irinotecan

Intravenously over 30 - 90 minutes

Drug: - Leucovorin

Intravenously over 30 - 90 minutes

Drug: - 5-FU

Intravenously bolus and intravenously for two days

Drug: - Gemcitabine

Intravenously over 30 minutes

Drug: - Cisplatin

Intravenously over 60 minutes

Drug: - Carboplatin

Intravenously per package insert

Drug: - Ramucirumab

Intravenously over 60 minutes

Drug: - Paclitaxel

Intravenously

Drug: - Nivolumab

Intravenously over 30 minutes

Drug: - Pembrolizumab

Intravenously over 30 minutes

Drug: - Imiquimod Cream

Topically

Drug: - Bevacizumab

Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses

Drug: - PLD

Intravenously over 60 minutes

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.

HonorHealth Research Institute, Scottsdale 5313457, Arizona 5551752

Status

Address

HonorHealth Research Institute

Scottsdale 5313457, Arizona 5551752, 85258

AOA-HOPE, Tucson 5318313, Arizona 5551752

Status

Address

AOA-HOPE

Tucson 5318313, Arizona 5551752, 85711

USC Norris Comprehensive Cancer Center, Los Angeles 5368361, California 5332921

Status

Address

USC Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

HOAG Memorial Hospital Presbyterian, Newport 5376887, California 5332921

Status

Address

HOAG Memorial Hospital Presbyterian

Newport 5376887, California 5332921, 92663

Ochsner Clinic Foundation, New Orleans 4335045, Louisiana 4331987

Status

Address

Ochsner Clinic Foundation

New Orleans 4335045, Louisiana 4331987, 70121

Atlantic Health System, Morristown 5101427, New Jersey 5101760

Status

Address

Atlantic Health System

Morristown 5101427, New Jersey 5101760, 07960

Perlmutter Cancer Center at NYU Langone, New York 5128581, New York 5128638

Status

Address

Perlmutter Cancer Center at NYU Langone

New York 5128581, New York 5128638, 10016

Eugene 5725846, Oregon 5744337

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Address

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)

Eugene 5725846, Oregon 5744337, 97401

Northwest Cancer Specialists, Portland 5746545, Oregon 5744337

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Address

Northwest Cancer Specialists

Portland 5746545, Oregon 5744337, 97227

Dallas 4684888, Texas 4736286

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Address

Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center

Dallas 4684888, Texas 4736286, 75246

Fort Worth 4691930, Texas 4736286

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Address

Texas Oncology - Downtown Fort Worth Cancer Center

Fort Worth 4691930, Texas 4736286, 76104

Virginia Cancer Specialists, PC, Leesburg 4769125, Virginia 6254928

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Address

Virginia Cancer Specialists, PC

Leesburg 4769125, Virginia 6254928, 20176

Medical College of Wisconsin, Milwaukee 5263045, Wisconsin 5279468

Status

Address

Medical College of Wisconsin

Milwaukee 5263045, Wisconsin 5279468, 53226

International Sites

Centre Léon Bérard, Lyon 2996944, France

Status

Address

Centre Léon Bérard

Lyon 2996944, , 69373

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