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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03872947
Other study ID # 950P1V02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 26, 2019
Est. completion date March 2025

Study information

Verified date May 2024
Source Toray Industries, Inc
Contact Vicki Bauernschub, BSN, RN
Phone 602 358 8324
Email vbauernschub@td2inc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel 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)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 187
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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. 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 - Arm 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 - 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. - 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 history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care - 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. - Arm S. Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with = 2 prior treatment lines who have recurred > 182 days after most recent platinum-based chemotherapy and who are eligible for carboplatin, PLD, and bevacizumab as standard of care - The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS) - Patients with or without the breast cancer susceptibility 1/2 (BRCA1/2) mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment - Arm T. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with = 5 prior treatment regimens, or as defined below, and who are eligible for paclitaxel as standard of care - 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 (complete response/remission (CR) or partial response/remission (PR), and then progressed between 90 days to less than 183 days after the last date of platinum. - Patients who have received multiple lines of platinum therapy must have progressed on the latest platinum, or within 183 days after the date of the last dose of the latest platinum - Patients with or without the BRCA1/2 mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment - Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy - The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS) - 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, 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). - 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

Study Design


Intervention

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

Locations

Country Name City State
France Centre Léon Bérard Lyon
United States Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center) Eugene Oregon
United States Texas Oncology - Downtown Fort Worth Cancer Center Fort Worth Texas
United States Virginia Cancer Specialists, PC Leesburg Virginia
United States USC Norris Comprehensive Cancer Center Los Angeles California
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Atlantic Health System Morristown New Jersey
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Perlmutter Cancer Center at NYU Langone New York New York
United States HOAG Memorial Hospital Presbyterian Newport California
United States Northwest Cancer Specialists Portland Oregon
United States HonorHealth Research Institute Scottsdale Arizona
United States AOA-HOPE Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 through study completion, an average of 1 year
Primary Frequency of patients experiencing adverse events of special interest (AESIs) through study completion, an average of 1 year
Primary Blood pressure mmHg through study completion, an average of 1 year
Primary Heart rate bpm through study completion, an average of 1 year
Primary Respiratory rate bpm through study completion, an average of 1 year
Primary Temperature °F or °C through study completion, an average of 1 year
Primary Weight lbs/kg through study completion, an average of 1 year
Primary Height inches/cm through study completion, an average of 1 year
Primary Performance status using Karnofsky performance status criteria through study completion, an average of 1 year
Primary QTc interval determined from 12-lead Electrocardiogram msec through study completion, an average of 1 year
Primary QRS interval determined from 12-lead Electrocardiogram msec through study completion, an average of 1 year
Primary Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry) through study completion, an average of 1 year
Secondary Overall response rate (ORR) through study completion, an average of 1 year
Secondary Disease Control Rate (DCR) through study completion, an average of 1 year
Secondary Serum concentration of TRK-950 through study completion, an average of 1 year
Secondary Plasma concentration of Gemcitabine for the first six patients in Arm K At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Secondary Plasma concentration of Carboplatin for the first six patients in Arm K At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Secondary Serum concentration of Bevacizumab for the first six patients in Arm K At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days)
Secondary Plasma concentration of PLD for the first six patients in Arm O At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days)
Secondary Serum concentration of Ramucirumab for the first six patients in Arm Q At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
Secondary Plasma concentration of Paclitaxel for the first six patients in Arm Q At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days)
Secondary Serum concentration of Bevacizumab for the first six patients in Arm R At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
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