Description:
This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a
humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult
subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in
combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with
pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.
Title
- Brief Title: CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
- Official Title: A PHASE 1/1b MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS
Clinical Trial IDs
- ORG STUDY ID:
CPI-006-001
- NCT ID:
NCT03454451
Conditions
- Non-Small Cell Lung Cancer
- Renal Cell Cancer
- Colorectal Cancer
- Triple Negative Breast Cancer
- Cervical Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Endometrial Cancer
- Sarcoma
- Squamous Cell Carcinoma of the Head and Neck
- Bladder Cancer
- Metastatic Castration Resistant Prostate Cancer
- Non-hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
CPI-006 | | Cohort 1a |
CPI-006 + ciforadenant | | Cohort1b |
CPI-006 + pembrolizumab | | Cohort 1c |
CPI-006 | | Cohort 2a |
CPI-006 + ciforadenant | | Cohort 2b |
CPI-006 + pembrolizumab | | Cohort 2c |
Purpose
This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a
humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult
subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in
combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with
pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1a | Experimental | CPI-006 | |
Cohort1b | Experimental | CPI-006 + ciforadenant | |
Cohort 1c | Experimental | CPI-006 + pembrolizumab | |
Cohort 2a | Experimental | CPI-006 | |
Cohort 2b | Experimental | CPI-006 + ciforadenant | |
Cohort 2c | Experimental | CPI-006 + pembrolizumab | |
Eligibility Criteria
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
2. Documented incurable cancer with one of the following histologies: nonsmall cell lung
cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with
microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer,
sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST
1.1).
4. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/
recurrent or progressing disease. For Expansion: Subject must have progressed on, be
refractory to, or intolerant to 1-3 prior systemic therapies.
5. Willingness to provide tumor biopsies.
Exclusion Criteria
1. History of severe hypersensitivity reaction to monoclonal antibodies.
2. Subjects who have received prior therapy with regimens containing
cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or
PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while
receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
3. History of (non-infectious) pneumonitis that required steroids or subject has current
pneumonitis.
4. The use of any investigational medication or device in the 30 days prior to screening
and throughout the study is prohibited.
5. Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. |
Time Frame: | From start of treatment to end of treatment, up to 36 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Area under the curve (AUC) of CPI-006 |
Time Frame: | Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). |
Safety Issue: | |
Description: | |
Measure: | Maximum serum concentration (Cmax) of CPI-006 |
Time Frame: | Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). |
Safety Issue: | |
Description: | |
Measure: | Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. |
Time Frame: | From start of treatment to end of treatment, up to 36 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Corvus Pharmaceuticals, Inc. |
Trial Keywords
- NSCLC
- RCC
- TNBC
- mCRPC
- CRC
- Lung Cancer
- Kidney Cancer
- Rectal Cancer
- Breast Cancer
- Sarcoma
- Endometrial
- Pancreatic
- Ovarian
- SCCHN
- NHL
Last Updated
July 27, 2021