Clinical Trials /

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

NCT03872947

Description:

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 for selected advanced solid tumors.

Related Conditions:
  • Bladder Carcinoma
  • Cholangiocarcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 950P1V02
  • NCT ID: NCT03872947

Conditions

  • Solid Tumor
  • Colon Cancer
  • Cholangiocarcinoma
  • Bladder Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Palpable Subcutaneous Malignant Lesions

Interventions

DrugSynonymsArms
TRK-950Arm A: TRK-950 + FOLFIRI
IrinotecanArm A: TRK-950 + FOLFIRI
LeucovorinArm A: TRK-950 + FOLFIRI
5-FUArm A: TRK-950 + FOLFIRI
GemcitabineArm B: TRK-950 + Gemcitabine/Cisplatin
CisplatinArm B: TRK-950 + Gemcitabine/Cisplatin
CarboplatinArm C: TRK-950 + Gemcitabine/Carboplatin
RamucirumabArm D: TRK-950 + Ramucirumab/Paclitaxel
PaclitaxelArm D: TRK-950 + Ramucirumab/Paclitaxel
NivolumabArm E: TRK-950 + PD1 inhibitors
PembrolizumabArm E: TRK-950 + PD1 inhibitors
Imiquimod CreamArm F: TRK-950 + Imiquimod Cream

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 for selected advanced solid tumors.

Detailed Description

      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
      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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A: TRK-950 + FOLFIRIExperimentalColon Cancer TRK-950 will be administered intravenously 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.
  • TRK-950
  • Irinotecan
  • Leucovorin
  • 5-FU
Arm B: TRK-950 + Gemcitabine/CisplatinExperimentalCholangiocarcinoma or Bladder Cancer TRK-950 will be administered intravenously 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 intravenous infusion.
  • TRK-950
  • Gemcitabine
  • Cisplatin
Arm C: TRK-950 + Gemcitabine/CarboplatinExperimentalOvarian Cancer TRK-950 will be administered intravenously 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 intravenously.
  • TRK-950
  • Gemcitabine
  • Carboplatin
Arm D: TRK-950 + Ramucirumab/PaclitaxelExperimentalGastric Cancer TRK-950 will be administered intravenously 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.
  • TRK-950
  • Ramucirumab
  • Paclitaxel
Arm E: TRK-950 + PD1 inhibitorsExperimental•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. On Day 1 and 15 after the administration of TRK-950, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered intravenously 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.
  • TRK-950
  • Nivolumab
  • Pembrolizumab
Arm F: TRK-950 + Imiquimod CreamExperimentalPalpable subcutaneous malignant lesions TRK-950 will be administered intravenously 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).
  • TRK-950
  • Imiquimod Cream

Eligibility Criteria

        Inclusion Criteria:

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

               -  A. Colon Cancer:FOLFIRI as standard of care

               -  B. Cholangiocarcinoma, Bladder Cancer: Gemcitabine / Cisplatin as standard of
                  care

               -  C. Ovarian Cancer who have relapsed at least 6 or more months after completion of
                  a previous platinum-based therapy: Gemcitabine / Carboplatin as standard of care

               -  D. Gastric Cancer: Ramucirumab / Paclitaxel as standard of care

               -  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

               -  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

          -  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, or investigational therapy within four weeks prior to
             study entry.

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:mmHg

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:
Measure:Plasma concentration of TRK-950
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Toray Industries, Inc

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