A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas



Status:Recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:May 2016
End Date:January 2020
Contact:Hongwei Wang
Email:clinicaltrials@curis.com

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A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients With Advanced Tumors and Lymphomas

CA-170 is a rationally designed and orally available, small molecule that directly targets
the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell
activation (VISTA) immune checkpoints and results in activation of T cell proliferation and
cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered
CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are
non-responsive to available therapies and for which no standard therapy exists.


Inclusion Criteria:

1. Males and females ≥ 18 years of age;

2. Life expectancy of at least 3 months;

3. ECOG PS ≤ 1;

4. Acceptable bone marrow and organ function at screening;

5. Ability to swallow and retain oral medications;

6. Negative serum pregnancy test in women of childbearing potential;

7. Measurable disease;

8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy,
when applicable, does not exist or is no longer effective. For patients enrolling into
backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to
have a high VISTA expression (such as metastatic malignant pleural mesothelioma of
epithelioid histology).

Exclusion Criteria:

1. Prior treatment anti-cancer therapy or use of any investigational agent within the
past 28 days or 5 half-lives, whichever is shorter;

2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;

3. Radiotherapy within the last 21 days;

4. Primary brain tumors or CNS metastases;

5. Major or minor surgery < 28 and <14 days from the start of treatment, respectively;

6. Active autoimmune disease or any medical condition requiring the use of systemic
immunosuppressive medications;

7. Endocrinopathies, unless on stable hormone replacement therapy;

8. Active infection requiring systemic therapy;

9. Receipt of live vaccines against infectious diseases within 28 days;

10. HIV positive or an AIDS-related illness;

11. Active/chronic HBV or HCV infection;

12. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass
graft surgery, TIA, or PE in prior 3 months;

13. Cardiac dysrhythmias;

14. Gastrointestinal disease that interferes with receipt of oral drugs;

15. Concomitant malignancy;

16. Pregnant or lactating female;
We found this trial at
12
sites
San Francisco, California 94143
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
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303 East Superior Street
Chicago, Illinois 60611
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Denver, CO
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Detroit, Michigan 48201
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Haven, Connecticut 06510
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New York, New York 10029
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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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Sarasota, Florida 34232
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Sarasota, FL
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Seoul,
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