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

Conditions

• Bladder Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Gastric Cancer
• Melanoma
• Ovarian Cancer
• Palpable Subcutaneous Malignant Lesions
• Primary Peritoneal Cancer
• Renal Cell Carcinoma
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TRK-950 — BIOLOGICAL
  10 mg/kg administered intravenously over 60 minutes (weekly)
• TRK-950 — BIOLOGICAL
  5 mg/kg administered intravenously over 60 minutes (weekly)
• TRK-950 — BIOLOGICAL
  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)
• Irinotecan — DRUG
  Intravenously over 30 - 90 minutes
• Leucovorin — DRUG
  Intravenously over 30 - 90 minutes
• 5-FU — DRUG
  Intravenously bolus and intravenously for two days
• Gemcitabine — DRUG
  Intravenously over 30 minutes
• Cisplatin — DRUG
  Intravenously over 60 minutes
• Carboplatin — DRUG
  Intravenously per package insert
• Ramucirumab — DRUG
  Intravenously over 60 minutes
• Paclitaxel — DRUG
  Intravenously
• Nivolumab — DRUG
  Intravenously over 30 minutes
• Pembrolizumab — DRUG
  Intravenously over 30 minutes
• Imiquimod Cream — DRUG
  Topically
• Bevacizumab — DRUG
  Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
• PLD — DRUG
  Intravenously over 60 minutes

Study Details

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.

Key Dates

Start date

Apr 26, 2019

Status verified

Jul 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

138 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: through study completion, an average of 1 year ]

Locations (13)

Find similar trials in Scottsdale, AZ

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