NeoplasmsPhase 1NCT03783403
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
A Phase 1 study testing CC-95251, Rituximab and Cetuximab in people with Neoplasms, run by Celgene at 31 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- CC-95251, Rituximab and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 1 Mar 2019to 5 Aug 2024
- 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
- Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
- Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
Who cannot join
- High-grade lymphomas (Burkitt's or lymphoblastic)
- Has cancer with symptomatic central nervous system (CNS) involvement
- History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
United States13 sites
Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
Aurora, Colorado, 80012
Local Institution - 105
Birmingham, Alabama, 35294
Local Institution - 109
Charlotte, North Carolina, 28204
Local Institution - 108
Houston, Texas, 77030
Local Institution - 102
Nashville, Tennessee, 37203-1625
Local Institution - 110
New York, New York, 10016
Local Institution - 106
Oklahoma City, Oklahoma, 73104
Local Institution - 107
Pittsburgh, Pennsylvania, 15232
Local Institution - 113
Portland, Oregon, 97213
Local Institution - 112
Sacramento, California, 95817
Local Institution - 103
San Antonio, Texas, 78229
Local Institution - 101
Scottsdale, Arizona, 85258
Local Institution - 115
St Louis, Missouri, 63110
France6 sites
Local Institution - 402
Borddeaux Cedex, 33076
Local Institution - 406
Créteil, 94010
Local Institution - 405
Marseille, 13009
Local Institution - 404
Nantes, 44093
Local Institution - 403
Rouen, 76038
Local Institution - 401
Villejuif, 94805
South Korea4 sites
Local Institution - 604
Seoul, 03722
Local Institution - 603
Seoul, 06351
Local Institution - 602
Seoul, 3080
Local Institution - 601
Seoul, 5505
Spain3 sites
Local Institution - 504
Madrid, 28040
Local Institution - 502
Málaga, 29010
Local Institution - 501
Salamanca, 37007
Australia2 sites
Local Institution - 301
Heidelberg, Victoria, 3084
Local Institution - 303
Melbourne, Victoria, 3000
Canada2 sites
Local Institution - 201
Edmonton, Alberta, T6G 1Z2
Local Institution - 202
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.
Read the detailed description
This is a test.
- Conditions
- Neoplasms
- Keywords
- Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-95251Drug
Specified dose on specified days
RituximabDrug
Specified dose on specified days
CetuximabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| CC-95251 | Experimental | Not described Receives: Drug: CC-95251 |
| CC-95251 in combination with rituximab | Experimental | Not described Receives: Drug: CC-95251; Drug: Rituximab |
| CC-95251 in combination with cetuximab | Experimental | Not described Receives: Drug: CC-95251; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Measured: 18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Measured: 18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Measured: 30 months
Secondary outcomes (9)
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Measured: 72 Months
Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
Measured: 66 Months
Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
Measured: 66 Months
Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
Measured: 66 Months
Overall survival (OS): Time from the first dose to death due to any cause
Measured: 66 Months
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Measured: 36 Months
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Measured: 36 Months
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Measured: 36 Months
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Mar 2019
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Why it stopped: Business objectives have changed.
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783403
- Sponsor's protocol ID
- CC-95251-ST-001
- Other IDs
- U1111-1224-8251
- Status last verified
- Sep 2024
- First submitted
- 19 Dec 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chan H, Trout CV, Mikolon D, Adams P, Guzman R, Mavrommatis K, Abbasian M, Hadjivassiliou H, Dearth L, Fox BA, Sivakumar P, Cho H, Hariharan K. Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPalpha That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies. Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634.
PubMed 38319147
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
- ClinicalTrials.gov ID
- NCT03783403
- Acronym / sponsor ID
- CC-95251-ST-001
- Conditions
- Neoplasms
- Keywords
- Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 206 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 21 Dec 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.
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.
Detailed description
This is a test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-95251 | Experimental | Drug: CC-95251 |
| CC-95251 in combination with rituximab | Experimental | Drug: CC-95251, Drug: Rituximab |
| CC-95251 in combination with cetuximab | Experimental | Drug: CC-95251, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
- Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
Key exclusion criteria (4 listed)
- High-grade lymphomas (Burkitt's or lymphoblastic)
- Has cancer with symptomatic central nervous system (CNS) involvement
- History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| CC-95251Specified dose on specified days | Drug | CC-95251, CC-95251 in combination with cetuximab, CC-95251 in combination with rituximab |
| RituximabSpecified dose on specified days | Drug | CC-95251 in combination with rituximab |
| CetuximabSpecified dose on specified days | Drug | CC-95251 in combination with cetuximab |
Primary outcome
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Time frame: 18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Time frame: 18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Time frame: 30 months
9 secondary outcomes
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Time frame: 72 Months
Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
Time frame: 66 Months
Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
Time frame: 66 Months
Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
Time frame: 66 Months
Overall survival (OS): Time from the first dose to death due to any cause
Time frame: 66 Months
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Time frame: 36 Months
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Time frame: 36 Months
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Time frame: 36 Months
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Time frame: 36 Months
Results and safety
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38319147Chan H, Trout CV, Mikolon D, Adams P, Guzman R, Mavrommatis K, Abbasian M, Hadjivassiliou H, Dearth L, Fox BA, Sivakumar P, Cho H, Hariharan K. Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPalpha That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies. Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-95251, Rituximab and Cetuximab in people with Neoplasms, run by Celgene at 31 sites in 7 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, France, South Korea, Spain, Australia and 2 more countries. 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 was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
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?
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects (time frame: 18 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 NCT03783403, 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 19 Sep 2024.