Description:
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.
Title
- Brief Title: A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
- Official Title: "A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma"
Clinical Trial IDs
- ORG STUDY ID:
CC-96673-NHL-001
- SECONDARY ID:
2020-004631-24
- NCT ID:
NCT04860466
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CC-96673 | | Administration of CC-96673 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Administration of CC-96673 | Experimental | CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule | |
Eligibility Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
1. Participant (male or female) is ≥ 18 years of age at the time of signing the informed
consent form (ICF).
2. Participant must understand and voluntarily sign an ICF prior to any study-related
assessments/procedures being conducted.
3. Participant is willing and able to adhere to the study visit schedule and other
protocol requirements.
4. Participant must have a history of NHL that has relapsed or progressed.
5. Participant has tumor accessible for biopsies.
6. Participant has an ECOG PS of 0 or 1.
7. Participants must have acceptable laboratory values as specified in the protocol.
Exclusion Criteria:
1. Participant has cancer with symptomatic central nervous system (CNS) involvement
2. 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.
3. Inadequate cardiac function or significant cardiovascular disease
4. Participant has received prior investigational therapy directed at CD47 or SIRPα.
5. Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
6. Participant is a pregnant or lactating female or intends to become pregnant during
participation of the study.
7. Participant has known active human immunodeficiency virus (HIV) infection.
8. Participant has active hepatitis B or C (HBV/HCV) infection.
9. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
10. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
11. History of concurrent second cancers requiring active, ongoing systemic treatment.
12. Participant has any significant medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from participating in the study.
13. Participant has active, uncontrolled, or suspected infection. Other protocol defined
inclusion/exclusion criteria could apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | From enrollment until at least 28 days after completion of study treatment |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Overall response rate (ORR) |
Time Frame: | Up to 2 years after study treatment |
Safety Issue: | |
Description: | Is defined as the percent of participants whose best response is CR or PR |
Measure: | Time to response (TTR) |
Time Frame: | Up to 2 years after study treatment |
Safety Issue: | |
Description: | Is defined as the time from the first dose of CC-96673 to tumor response |
Measure: | Duration of response (DOR) |
Time Frame: | Up to 2 years after study treatment |
Safety Issue: | |
Description: | Is defined as the time from tumor response to progression/death |
Measure: | Progression free survival (PFS) |
Time Frame: | Up to 2 years after study treatment |
Safety Issue: | |
Description: | Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause |
Measure: | Pharmacokinetics - Cmax |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Maximum observed serum concentration of drug |
Measure: | Pharmacokinetics - Cmin |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Observed serum concentration of drug at the end of a dosing interval |
Measure: | Pharmacokinetics - AUC |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Area under the serum concentration-time curve |
Measure: | Pharmacokinetics - tmax |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Time of maximum observed serum concentration |
Measure: | Pharmacokinetics - t1/2 |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Terminal half-life |
Measure: | Pharmacokinetics - CL |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Total body clearance |
Measure: | Pharmacokinetics - Vss |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Volume of distribution at steady-state |
Measure: | Pharmacokinetics - Accumulation ratio |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Accumulation ratio |
Measure: | Presence of Anti-drug antibodies (ADA) |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Determined by using a validated bridging immunoassay with electrochemiluminescence detection |
Measure: | Frequency of Anti-drug antibodies (ADA) |
Time Frame: | Up to 24 Months |
Safety Issue: | |
Description: | Determined by using a validated bridging immunoassay with electrochemiluminescence detection |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Celgene |
Trial Keywords
- Relapsed or Refractory
- Non-Hodgkin's Lymphoma
- CC-96673
- Dose Finding
Last Updated
June 24, 2021