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Trial record 1 of 2 for:    CA-170
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02812875
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 26, 2020
Information provided by (Responsible Party):
Curis, Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors or Lymphomas Drug: CA-170 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2016
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : May 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CA-170
Taken orally in a once or twice daily schedule.
Drug: CA-170

Dose escalation stage (Phase 1a) accelerated titration and standard 3+3 dose escalation in patients with advanced solid tumor or lymphoma.

Dose expansion stage (Phase 1b) in patients with tumors that are shown to be responsive to anti-PD-1 or anti-PD-L1 checkpoint inhibitors and/or in tumor types known to express PD-L1 or VISTA, including but not limited to: mesothelioma, melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, triple negative breast cancer, head and neck cancer, colorectal cancer, gastric cancer, bladder cancer, and ovarian cancer.

Primary Outcome Measures :
  1. The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: Approximately 24 months ]
  2. Maximum tolerated dose (MTD) of CA-170 [ Time Frame: Approximately 24 months ]
  3. Recommended Phase 2 Dose (RP2D) of CA-170 [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
    Maximum Concentration (Cmax)

  2. Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
    Area Under the Curve (AUC)

  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812875

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Sponsors and Collaborators
Curis, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02812875    
Other Study ID Numbers: CA-170-101
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Curis, Inc.:
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases