A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

Titre officiel

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

Sommaire:

L’étude CC-95251-ST-001 est une étude clinique ouverte de phase I d’augmentation de la dose (partie A) et d’expansion de la dose (partie B) menée pour la première fois chez l’humain et portant sur l’emploi du CC-95251 chez des sujets atteints de tumeurs solides de stade avancé.

Description de l'essai

Primary Outcome:

• Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
• Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
• Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria

• Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
• Time to response (TTR): Time from the first dose to the first objective tumour response observed for participants who achieved a CR or PR
• Duration of response (DOR): Time from the first objective tumour response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
• Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
• Overall survival (OS): Time from the first dose to death due to any cause
• Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
• Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
• Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
• Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies

Voir cet essai sur ClinicalTrials.gov