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BRIEF 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

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


  • Org Study ID: 950P1V02
  • Secondary ID:
  • NCT ID: NCT03872947
  • NCT Alias:
  • Sponsor: Toray Industries, Inc - Industry
  • Source: Toray Industries, Inc

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 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
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.

Overal Status Start Date Phase Study Type
Recruiting April 26, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0

Primary Outcome 1 - Time Frame: through study completion, an average of 1 year

Primary Outcome 2 - Measure: Blood pressure

Primary Outcome 2 - Time Frame: through study completion, an average of 1 year

Primary Outcome 3 - Measure: Heart rate

Primary Outcome 3 - Time Frame: through study completion, an average of 1 year

Primary Outcome 4 - Measure: Respiratory rate

Primary Outcome 4 - Time Frame: through study completion, an average of 1 year

Primary Outcome 5 - Measure: Temperature

Primary Outcome 5 - Time Frame: through study completion, an average of 1 year

Primary Outcome 6 - Measure: Weight

Primary Outcome 6 - Time Frame: through study completion, an average of 1 year

Primary Outcome 7 - Measure: Height

Primary Outcome 7 - Time Frame: through study completion, an average of 1 year

Primary Outcome 8 - Measure: Performance status using Karnofsky performance status criteria

Primary Outcome 8 - Time Frame: through study completion, an average of 1 year

Primary Outcome 9 - Measure: QTc interval determined from 12-lead Electrocardiogram

Primary Outcome 9 - Time Frame: through study completion, an average of 1 year

Primary Outcome 10 - Measure: QRS interval determined from 12-lead Electrocardiogram

Primary Outcome 10 - Time Frame: through study completion, an average of 1 year

Primary Outcome 11 - Measure: Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)

Primary Outcome 11 - Time Frame: through study completion, an average of 1 year

Condition:

  • Solid Tumor
  • Colon Cancer
  • Cholangiocarcinoma
  • Bladder Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Palpable Subcutaneous Malignant Lesions

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed solid malignancy for which the following treatment regimens
are warranted:

- A. Colon Cancer:FOLFIRI as standard of care

- B. Cholangiocarcinoma, Bladder Cancer: 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: Gemcitabine / Carboplatin as standard of care

- D. Gastric Cancer: 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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Vicki Bauernschub, BSN, RN

Phone: 602 358 8324

Email: vbauernschub@td2inc.com

Locations

Facility Status Contact
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer, MSN,RN,AOCNS
480-323-1339
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Recruiting Amanda Woolery, RN

Amanda.woolery@ochsner.org
Atlantic Health System
Morristown, New Jersey 07960
United States
Recruiting Angela Alistar, Dr.
973-971-7960
Angela.Alistar@atlantichealth.org
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Medical College of Wisconsin
866-680-0505
cccto@mcw.edu