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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2024
  • participants needed
    169
  • sponsor
    Toray Industries, Inc
Updated on 25 October 2022
ct scan
paclitaxel
cancer
combinations
carcinoma
fluorouracil
doxorubicin
metastasis
carboplatin
gemcitabine
pembrolizumab
leucovorin
irinotecan
bevacizumab
ramucirumab
nivolumab
ipilimumab
cancer treatment
cancer chemotherapy
solid tumour
ovarian cancer
fallopian tube
bladder cancer
taxane
5-fluorouracil
cisplatin/gemcitabine
bladder tumor
platinum-based chemotherapy
topotecan
pd-1 inhibitor
cancer of the ovary
clear cell renal cell carcinoma

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, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors.

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 8) Gemcitabine / Carboplatin / Bevacizumab, 9) Topotecan, or 10) PLD 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.

Details
Condition 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
Treatment cisplatin, Topotecan, carboplatin, Gemcitabine, Ipilimumab, Paclitaxel, bevacizumab, Pembrolizumab, Irinotecan, 5-FU, Leucovorin, Nivolumab, Ramucirumab, PLD, TRK-950, Imiquimod Cream
Clinical Study IdentifierNCT03872947
SponsorToray Industries, Inc
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

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 and Expansion Cohort 1. 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 and Expansion Cohort 2. 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(Lower-dose)
Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
Arms M and 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(Lower-dose)
Life expectancy of at least 3 months
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
Signed, written IRB-approved informed consent
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. (Lower-dose)
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
Karnofsky performance of ≥70
history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for
metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of
Age ≥ 18 years
care (Lower-dose)

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
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
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)
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