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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 : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : May 6, 2019
Sponsor:
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)
Estimated Enrollment : 300 participants
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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 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
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;

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


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
United States, Florida
Sarah Cannon Research Institute
Sarasota, Florida, United States, 34232
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15237
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Yonsei University Health System - Severance Hospital
Seoul, Korea, Republic of, 3722
Asan Medical Center
Seoul, Korea, Republic of, 5505
Spain
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Catalan Institute of Oncology
Barcelona, Spain, 08907
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Curis, Inc.

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Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02812875     History of Changes
Other Study ID Numbers: CA-170-101
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Curis, Inc.:
Mesothelioma
PD-L1
VISTA
PD-1
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases