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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors or Lymphomas | Drug: CA-170 | Phase 1 |
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 |
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. |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females ≥ 18 years of age;
- Life expectancy of at least 3 months;
- ECOG PS ≤ 1;
- Acceptable bone marrow and organ function at screening;
- Ability to swallow and retain oral medications;
- Negative serum pregnancy test in women of childbearing potential;
- Measurable disease;
- 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:
- Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
- Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
- Radiotherapy within the last 21 days;
- Primary brain tumors or CNS metastases;
- Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
- Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
- Endocrinopathies, unless on stable hormone replacement therapy;
- Active infection requiring systemic therapy;
- Receipt of live vaccines against infectious diseases within 28 days;
- HIV positive or an AIDS-related illness;
- Active/chronic HBV or HCV infection;
- Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
- Cardiac dysrhythmias;
- Gastrointestinal disease that interferes with receipt of oral drugs;
- Concomitant malignancy;
- Pregnant or lactating female;

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

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 |
Mesothelioma PD-L1 VISTA PD-1 |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |