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
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors or Lymphomas||Drug: CA-170||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Taken orally in a once or twice daily schedule.
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 ]
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