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, Bevacizumab, as well as Nivolumab / Ipilimumab for selected advanced solid tumors.

Related Conditions:
  • Bladder Carcinoma
  • Cholangiocarcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Renal Cell 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
  • Renal Cell Carcinoma
  • Melanoma

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
BevacizumabArm G: TRK-950 + Bevacizumab
IpilimumabArm I: TRK-950 + Nivolumab/Ipilimumab

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, as well as Nivolumab / Ipilimumab 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
      7) Bevacizumab or 8) Nivolumab / Ipilimumab 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 + FOLFIRIExperimentalColorectal 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. 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 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
Arm G: TRK-950 + BevacizumabExperimentalRenal Cell Carcinoma 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, Bevacizumab will be administered as an IV infusion.
  • TRK-950
  • Bevacizumab
Arm H: TRK-950 + PD1 inhibitorsExperimentalMelanoma H-1: TRK-950 + Nivolumab •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, Nivolumab will be administered as an IV infusion. H-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 I: TRK-950 + Nivolumab/IpilimumabExperimentalMelanoma 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, Nivolumab will be administered as an IV infusion. In cycles 1 through 4 only, after the infusion of Nivolumab, Ipilimumab will be administered intravenously. This cycle will be repeated for four (4) cycles. Beginning with cycle 5, TRK-950 will be administered 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.
  • TRK-950
  • Nivolumab
  • Ipilimumab
Arm J: TRK-950 + FOLFIRIExperimentalColorectal 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

Eligibility Criteria

        Inclusion Criteria:

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

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

               -  B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with
                  Gemcitabine alone or in combination: 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 and have no prior history of treatment with
                  gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of
                  care

               -  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

               -  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 (US Sites Only)

               -  G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone
                  or in combination: Bevacizumab as standard of care

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

               -  I. Melanoma patients who have not been treated with Nivolumab, Pembrolizumab, or
                  Ipilimumab: Nivolumab / Ipilimumab as standard of care

               -  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

          -  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

Last Updated

March 27, 2020