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 |
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.
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
3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
![Sarah Cannon Research Institute](/wp-content/uploads/logos/sarah-cannon-research-institute.jpg)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
![University of Texas M.D. Anderson Cancer Center](/wp-content/uploads/logos/university-of-texas-m-d-anderson-cancer-center.gif)
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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