A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Details
Study Description
Brief Summary
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).
The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.
Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-96673 CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule |
Drug: CC-96673
IV Infusion
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events (AEs) [From enrollment until at least 28 days after completion of study treatment]
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
- Dose-limiting toxicity (DLT) [Up to approximately 18 months]
Number of participants with a DLT
- Maximum tolerated dose (MTD) [Up to approximately 18 months]
Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.
Secondary Outcome Measures
- Overall response rate (ORR) [Up to 2 years after study treatment]
Is defined as the percent of participants whose best response is CR or PR
- Time to response (TTR) [Up to 2 years after study treatment]
Is defined as the time from the first dose of CC-96673 to tumor response
- Duration of response (DOR) [Up to 2 years after study treatment]
Is defined as the time from tumor response to progression/death
- Progression free survival (PFS) [Up to 2 years after study treatment]
Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
- Pharmacokinetics - Cmax [Up to 24 Months]
Maximum observed serum concentration of drug
- Pharmacokinetics - Cmin [Up to 24 Months]
Observed serum concentration of drug at the end of a dosing interval
- Pharmacokinetics - AUC [Up to 24 Months]
Area under the serum concentration-time curve
- Pharmacokinetics - tmax [Up to 24 Months]
Time of maximum observed serum concentration
- Pharmacokinetics - t1/2 [Up to 24 Months]
Terminal half-life
- Pharmacokinetics - CL [Up to 24 Months]
Total body clearance
- Pharmacokinetics - Vss [Up to 24 Months]
Volume of distribution at steady-state
- Pharmacokinetics - Accumulation ratio [Up to 24 Months]
Accumulation ratio
- Presence of Anti-drug antibodies (ADA) [Up to 24 Months]
Determined by using a validated bridging immunoassay with electrochemiluminescence detection
- Frequency of Anti-drug antibodies (ADA) [Up to 24 Months]
Determined by using a validated bridging immunoassay with electrochemiluminescence detection
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
-
Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
-
Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
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Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
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Participant must have a history of NHL that has relapsed or progressed.
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Participant has tumor accessible for biopsies.
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Participant has an ECOG PS of 0 or 1.
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Participants must have acceptable laboratory values as specified in the protocol.
Exclusion Criteria:
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Participant has cancer with symptomatic central nervous system (CNS) involvement
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Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion.
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Inadequate cardiac function or significant cardiovascular disease
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Participant has received prior investigational therapy directed at CD47 or SIRPα.
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Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
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Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.
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Participant has known active human immunodeficiency virus (HIV) infection.
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Participant has active hepatitis B or C (HBV/HCV) infection.
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Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
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History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
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History of concurrent second cancers requiring active, ongoing systemic treatment.
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Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
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Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 2 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6840 |
| 3 | The University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 4 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 5 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
| 6 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 7 | Hopital Claude Huriez | Lille | France | 59037 | |
| 8 | Local Institution - 303 | Lille | France | 59037 | |
| 9 | CHU Montpellier - Hôpital Saint Eloi | Montpellier CEDEX 5 | France | 34295 | |
| 10 | Hopital Lyon Sud | Pierre Benite | France | 69310 | |
| 11 | Clinica Universidad de Navarra | Madrid | Spain | 28027 | |
| 12 | Local Institution - 401 | Madrid | Spain | 28027 | |
| 13 | Hospital Universitario Virgen de la Victoria | Malaga | Spain | 29010 | |
| 14 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CC-96673-NHL-001
- 2020-004631-24