A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Titre officiel

A Phase I, Multi-centre, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

Sommaire:

L’étude CC-99282-NHL-001 est une étude clinique d’augmentation de la dose et d’expansion de phase I du CC-99282 administré seul et en association avec le rituximab chez des sujets atteints de lymphomes non hodgkiniens récidivants ou réfractaires (LNH R/R).

Description de l'essai

Primary Outcome:

• Dose Limiting Toxicity (DLT)
• Maximum tolerated dose (MTD)
• Incidence of Adverse Events (AEs)

• Pharmacokinetics - Maximum observed plasma concentration (Cmax)
• Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
• Pharmacokinetics - Time to Cmax (Tmax)
• Pharmacokinetics - Terminal-phase elimination half-life (t1/2)
• Pharmacokinetics - Apparent total clearance of the drug from plasma after oral administration (CL/F)
• Pharmacokinetics: Apparent volume of distribution during terminal phase after non-intravenous administration (V/F)
• Objective response rate (ORR)
• Time to response (TTR)
• Duration of response (DoR)
• Progression free survival: Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause
• Overall survival: Time from first dose of CC-99282 to death from any cause

Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy).

The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy.

The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and R/R FL.

Voir cet essai sur ClinicalTrials.gov