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CA-170

Phase 1

Advanced Solid Tumors or Lymphomas | Small molecule | Oncology |Curis, Inc.|Last Updated: Jun 26, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02812875A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and LymphomasPHASE1 COMPLETED 71May 1, 2016May 7, 2020Jun 26, 202020 United States, South Korea +2
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Study Endpoints
Primary Endpoints
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle
Approximately 24 months
Maximum tolerated dose (MTD) of CA-170
Approximately 24 months
Recommended Phase 2 Dose (RP2D) of CA-170
Approximately 24 months
Secondary Endpoints
Pharmacokinetic (PK) Profile of CA-170
From Day 1 of Cycle 1(each cycle is 21 days)
Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma
36 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CA-170EXPERIMENTALTaken orally in a once or twice daily schedule.
Interventions
NameTypeDescription
CA-170DRUGDose 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

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. ...

Countries:United StatesSouth KoreaSpainUnited Kingdom
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