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

Brief Summary

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.

Tracking Information
First Received DateJune 14, 2016
Last Changed DateOctober 26, 2018
Start DateMay 2016
Anticipated Primary Completion DateJanuary 2019
Primary Outcome Measures

The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [Time Frame: Approximately 24 months]

Maximum tolerated dose (MTD) of CA-170 [Time Frame: Approximately 24 months]

Recommended Phase 2 Dose (RP2D) of CA-170 [Time Frame: Approximately 24 months]

Secondary Outcome Measures

Pharmacokinetic (PK) Profile of CA-170 [Time Frame: From Day 1 of Cycle 1(each cycle is 21 days)]

Pharmacokinetic (PK) Profile of CA-170 [Time Frame: From Day 1 of Cycle 1(each cycle is 21 days)]

Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma [Time Frame: 36 months]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Advanced Solid Tumors or Lymphomas
Intervention
  • Drug: CA-170
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment300
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Hongwei Wang
Email: clinicaltrials@curis.com
Eligibility Criteria

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;

Administrative Information
NCTIDNCT02812875
Responsible PartySponsor
SponsorCuris, Inc.
Verification DateFebruary 2018
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