Neoplasms Clinical Trial
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
| Verified date | November 2023 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 230 |
| Est. completion date | August 23, 2024 |
| Est. primary completion date | June 20, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 301 | Heidelberg | Victoria |
| Australia | Local Institution - 303 | Melbourne | Victoria |
| Canada | Local Institution - 201 | Edmonton | Alberta |
| Canada | Local Institution - 202 | Toronto | Ontario |
| France | Local Institution - 402 | Borddeaux Cedex | |
| France | Local Institution - 406 | Creteil | |
| France | Local Institution - 405 | Marseille | |
| France | Local Institution - 404 | Nantes Cedex 01 | |
| France | Local Institution - 403 | Rouen | |
| France | Local Institution - 401 | Villejuif CEDEX | |
| Italy | Local Institution - 701 | Bologna | |
| Italy | Local Institution - 702 | Napoli, Campania | |
| Korea, Republic of | Local Institution - 601 | Seoul | |
| Korea, Republic of | Local Institution - 602 | Seoul | |
| Korea, Republic of | Local Institution - 603 | Seoul | |
| Korea, Republic of | Local Institution - 604 | Seoul | |
| Spain | Local Institution - 504 | Madrid | |
| Spain | Local Institution - 502 | Malaga | |
| Spain | Local Institution - 501 | Salamanca | |
| United Kingdom | Local Institution - 802 | Manchester | |
| United States | Rocky Mountain Cancer Centers, LLP [Aurora-COAU] | Aurora | Colorado |
| United States | Local Institution - 105 | Birmingham | Alabama |
| United States | Local Institution - 109 | Charlotte | North Carolina |
| United States | Local Institution - 108 | Houston | Texas |
| United States | Local Institution - 102 | Nashville | Tennessee |
| United States | Local Institution - 110 | New York | New York |
| United States | Local Institution - 106 | Oklahoma City | Oklahoma |
| United States | Local Institution - 107 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 113 | Portland | Oregon |
| United States | Local Institution - 112 | Sacramento | California |
| United States | Local Institution - 115 | Saint Louis | Missouri |
| United States | Local Institution - 103 | San Antonio | Texas |
| United States | Local Institution - 101 | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Australia, Canada, France, Italy, Korea, Republic of, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects | 18 months | ||
| Primary | Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects | 18 months | ||
| Primary | Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria | 30 months | ||
| Secondary | Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) | 72 Months | ||
| Secondary | Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR | 66 Months | ||
| Secondary | 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 | 66 Months | ||
| Secondary | Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause | 66 Months | ||
| Secondary | Overall survival (OS): Time from the first dose to death due to any cause | 66 Months | ||
| Secondary | Pharmacokinetic - Maximum serum concentration of the drug (Cmax) | 36 Months | ||
| Secondary | Pharmacokinetic - Minimum serum concentration of the drug (Cmin) | 36 Months | ||
| Secondary | Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) | 36 Months | ||
| Secondary | Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies | 36 Months |
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