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,
Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD)
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 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.
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 (IV) 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
169
Start Date
April 26, 2019
Completion Date
August 2024
Primary Completion Date
August 2024
Eligibility Criteria
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)
- 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)
- 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 (Lower-dose)
- 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)
- 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
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
October 2022