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

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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

Brief Summary

      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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0

Secondary Outcome

 Overall response rate (ORR)

Condition

Solid Tumor

Intervention

TRK-950

Study Arms / Comparison Groups

 Arm A: TRK-950 + FOLFIRI
Description:  Colorectal 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

75

Start Date

April 26, 2019

Completion Date

April 2021

Primary Completion Date

April 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 602 358 8324, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03872947

Organization ID

950P1V02


Responsible Party

Sponsor

Study Sponsor

Toray Industries, Inc


Study Sponsor

, , 


Verification Date

March 2020