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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Toray Industries, Inc
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Cisplatin; Gemcitabine; Imiquimod; Ipilimumab; Irinotecan; Leucovorin; Nivolumab; Paclitaxel; Pembrolizumab; Ramucirumab; Topotecan

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)

• Arm L(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 M. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, who have recurred ≤ 6 months after most recent platinum-based chemotherapy and who are eligible for topotecan as standard of care for dosing of TRK-950(Lower-dose)

• Arm O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, who have recurred ≤ 6 months after most recent platinum-based chemotherapy and who are eligible for pegylated liposomal doxorubicin as standard of care for dosing of TRK-950(Lower-dose)

• 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: eligible to receive Ramucirumab/Paclitaxel as standard of care (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, or investigational therapy within four weeks prior to initiation of study treatment.

• 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