Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/19/2018
Start Date:January 2016
End Date:September 2020
Contact:Cyndi Sirard, MD
Email:CSirard@leaptx.com
Phone:(617) 714-0357

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A Phase 1 Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab in Adults With Advanced Solid Tumors

This study will be conducted in 5 parts (Parts A, B, C, D and E).

Monotherapy Treatment:

Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Monotherapy dose
escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for
safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be
assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in
which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once
the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an
expanded cohort will be enrolled (Part B).

Combination Treatment:

Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Subjects will
receive TRX518 in combination with gemcitabine (Part C), pembrolizumab (Part D), or nivolumab
(Part E). Dose escalation will be performed for each part (Part Cesc, Part Desc, Part Eesc)
and Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities
(DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening
is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts
will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or
maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled
(Part Cexp, Part Dexp, Part Eexp).


Inclusion Criteria:

- Advanced Solid Malignancies: Histologically documented metastatic or locally advanced,
incurable solid malignancy (Parts A and B); histologically documented metastatic or
locally advanced, incurable solid malignancy for which gemcitabine is clinically
appropriate (e.g., non-small cell lung, breast, ovarian, pancreatic, and renal
cancer); histologically documented metastatic or locally advanced, incurable solid
malignancy for which pembrolizumab (Part D) or nivolumab (Part E) is approved. NOTE:
Parts D and E only: Subject has either (1) received treatment with pembrolizumab or
nivolumab for ≥4 months with a best response of stable disease and plans to continue
treatment with either pembrolizumab or nivolumab in accordance with package insert; or
(2) is not currently taking, but is eligible for treatment with, pembrolizumab or
nivolumab in accordance with the approved indications for each as referenced in the
package insert.

- Expected survival of at least 12 weeks after dosing.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Evidence of adequate organ function by standard laboratory tests.

- All female subjects of child bearing age must be either surgically sterile,
postmenopausal for at least 1 year, or using an acceptable method of contraception.
Adequate contraception for both male and female subjects must be used from the
beginning of the screening period until at least 8 weeks after the last dose of study
drug.

Exclusion Criteria:

- Hematologic malignancies or multiple myeloma.

- Known, clinically important cardiac or respiratory disease

- Any concomitant serious physical illness other than cancer (e.g., immune deficiency
disease, bleeding disorder, etc.) within 1 year prior to dosing. No history of
autoimmune disease.

- Active, uncontrolled infections within 7 days of study entry requiring systemic
therapy.

- Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS
metastases within 30 days prior to dosing.

- History of known or suspected autoimmune disease with the specific exceptions of
vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment. (Parts C,
D and E only).

- Clinically-significant gastrointestinal disorders, such as perforation,
gastrointestinal bleeding, or diverticulitis (Parts D and E only).

- Active autoimmune disease that has required systemic treatment in past 2 years (i.e.
with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
systemic treatment (Parts D and E only).

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis
(Parts D and E only).

- History of interstitial lung disease (Parts D and E only).
We found this trial at
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5801 South Ellis Avenue
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, Ohio 44106
Phone: 216-844-0120
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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