Non-Small Cell Lung CancerPhase 1NCT03454451
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
A Phase 1 study testing CPI-006, CPI-006 + ciforadenant and CPI-006 + pembrolizumab in people with Non-Small Cell Lung Cancer and Renal Cell Cancer, run by Corvus Pharmaceuticals, Inc. at 27 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer
- What is being tested?
- CPI-006, CPI-006 + ciforadenant and CPI-006 + pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 25 Apr 2018to 19 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- 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.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- 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.
- Willingness to provide tumor biopsies.
Who cannot join
- History of severe hypersensitivity reaction to monoclonal antibodies.
- 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.
- History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
- The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States22 sites
NY Hematology
Albany, New York, 12206
The John Hopkins University
Baltimore, Maryland, 21224
Dana Farber
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60611
The University of Chicago
Chicago, Illinois, 60637
Oncology Hematology Care
Cincinnati, Ohio, 45242
Mary Crowley Cancer Research
Dallas, Texas, 75230
City Of Hope
Duarte, California, 91010
Virginia Cancer
Fairfax, Virginia, 22031
Greenville
Greenville, South Carolina, 29605
Carolina BioOncology Institute
Huntsville, North Carolina, 28078
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of Miami
Miami, Florida, 33136
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale School of Medicine
New Haven, Connecticut, 06519
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
UPMC Hillman
Pittsburgh, Pennsylvania, 15232
UC San Francisco
San Francisco, California, 94143
Arizona Oncology
Tucson, Arizona, 85711
Australia5 sites
Lifehouse
Camperdown, New South Wales, 2050
Monash Hospital
Clayton, Victoria, 3168
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Royal Brisbane
Herston, Queensland, 4029
Westmead
Westmead, New South Wales, 3168
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Cervical Cancer, Ovarian Cancer
- Being tested
- CPI-006, CPI-006 + ciforadenant, CPI-006 + pembrolizumab
- Keywords
- NSCLC, RCC, TNBC, mCRPC, CRC, Lung Cancer, Kidney Cancer, Rectal Cancer, Breast Cancer, Sarcoma, Endometrial, Pancreatic, Ovarian, SCCHN, NHL
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-006Drug
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
CPI-006 + ciforadenantDrug
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
CPI-006 + pembrolizumabDrug
Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
CPI-006Drug
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
CPI-006 + ciforadenantDrug
Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
CPI-006 + pembrolizumabDrug
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a | Experimental | CPI-006 Receives: Drug: CPI-006 |
| Cohort1b | Experimental | CPI-006 + ciforadenant Receives: Drug: CPI-006 + ciforadenant |
| Cohort 1c | Experimental | CPI-006 + pembrolizumab Receives: Drug: CPI-006 + pembrolizumab |
| Cohort 2a | Experimental | CPI-006 Receives: Drug: CPI-006 |
| Cohort 2b | Experimental | CPI-006 + ciforadenant Receives: Drug: CPI-006 + ciforadenant |
| Cohort 2c | Experimental | CPI-006 + pembrolizumab Receives: Drug: CPI-006 + pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Measured: From start of treatment to end of treatment, up to 36 months
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Measured: From start of treatment to end of treatment, up to 36 months
Identify the MDL(maximum dose level) of single agent CPI-006
Measured: From start of treatment to end of treatment, up to 36 months
Secondary outcomes (3)
Area under the curve (AUC) of CPI-006
Measured: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Maximum serum concentration (Cmax) of CPI-006
Measured: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Measured: From start of treatment to end of treatment, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start25 Apr 2018
- Primary completion28 Dec 2022
- Study completion19 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Mahabhashyam, MD, Study chair, Corvus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454451
- Sponsor's protocol ID
- CPI-006-001
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Miller RA, Luke JJ, Hu S, Mahabhashyam S, Jones WB, Marron T, Merchan JR, Hughes BGM, Willingham SB. Anti-CD73 antibody activates human B cells, enhances humoral responses and induces redistribution of B cells in patients with cancer. J Immunother Cancer. 2022 Dec;10(12):e005802. doi: 10.1136/jitc-2022-005802.
PubMed 36600561
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03454451
- Acronym / sponsor ID
- CPI-006-001
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Cervical Cancer, Ovarian Cancer
- Keywords
- NSCLC, RCC, TNBC, mCRPC, CRC, Lung Cancer, Kidney Cancer, Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 19 Feb 2023 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a | Experimental | Drug: CPI-006CPI-006 |
| Cohort1b | Experimental | Drug: CPI-006 + ciforadenantCPI-006 + ciforadenant |
| Cohort 1c | Experimental | Drug: CPI-006 + pembrolizumabCPI-006 + pembrolizumab |
| Cohort 2a | Experimental | Drug: CPI-006CPI-006 |
| Cohort 2b | Experimental | Drug: CPI-006 + ciforadenantCPI-006 + ciforadenant |
| Cohort 2c | Experimental | Drug: CPI-006 + pembrolizumabCPI-006 + pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- 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.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- 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.
- Willingness to provide tumor biopsies.
Key exclusion criteria (5 listed)
- History of severe hypersensitivity reaction to monoclonal antibodies.
- 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.
- History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
- The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-006Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression. | Drug | Cohort 1a |
| CPI-006 + ciforadenantSubjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression. | Drug | Cohort1b |
| CPI-006 + pembrolizumabSubjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression. | Drug | Cohort 1c |
| CPI-006Selected dose of CPI-006 administered intravenously once every 21 days until disease progression. | Drug | Cohort 2a |
| CPI-006 + ciforadenantSelected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression. | Drug | Cohort 2b |
| CPI-006 + pembrolizumabSelected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression. | Drug | Cohort 2c |
Primary outcome
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
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, 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
Identify the MDL(maximum dose level) of single agent CPI-006
Time frame: From start of treatment to end of treatment, up to 36 months
3 secondary outcomes
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).
Maximum serum concentration (Cmax) of CPI-006
Time frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 36600561Miller RA, Luke JJ, Hu S, Mahabhashyam S, Jones WB, Marron T, Merchan JR, Hughes BGM, Willingham SB. Anti-CD73 antibody activates human B cells, enhances humoral responses and induces redistribution of B cells in patients with cancer. J Immunother Cancer. 2022 Dec;10(12):e005802. doi: 10.1136/jitc-2022-005802.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S Mahabhashyam, MD study chair
Corvus Pharmaceuticals
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-006, CPI-006 + ciforadenant and CPI-006 + pembrolizumab in people with Non-Small Cell Lung Cancer and Renal Cell Cancer, run by Corvus Pharmaceuticals, Inc. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.