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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

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ClinicalTrials.gov Identifier: NCT02812875
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Curis, Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date March 1, 2019
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: 43 weeks ]
  • Maximum tolerated dose (MTD) of CA-170 [ Time Frame: 21 Days ]
  • Recommended Phase 2 Dose (RP2D) of CA-170 [ Time Frame: Approximately 18 months ]
Change History Complete list of historical versions of study NCT02812875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
    Maximum Concentration (Cmax)
  • Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
    Area Under the Curve (AUC)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • Maximum Concentration (Cmax) [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
  • Area Under the Curve (AUC) [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]
  • Exploratory Outcome Measure: Preliminary clinical efficacy based on RECIST [ Time Frame: 1 year ]
  • Exploratory Outcome Measure: Preliminary clinical efficacy based on irRECIST [ Time Frame: 1 year ]
  • Exploratory Outcome Measure: Preliminary clinical efficacy based on Cheson [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors or Lymphomas
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: CA-170
Taken orally in a once or twice daily schedule.
Intervention: Drug: CA-170
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
300
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
150
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongwei Wang clinicaltrials@curis.com
Listed Location Countries  ICMJE Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812875
Other Study ID Numbers  ICMJE CA-170-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Curis, Inc.
Study Sponsor  ICMJE Curis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Curis, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP