First in Human Study of M6223 in Participants With Metastatic or Locally Advanced Solid Unresectable Tumours

Titre officiel

Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa, Anti-PDL1/ TGFß Trap in, Participants With Metastatic or Locally Advanced Solid Unresectable Tumours

Sommaire:

L’objectif principal de cette étude est de déterminer l’innocuité, la tolérabilité, les paramètres pharmacocinétiques, l’immunogénicité et (si elle est observée) la dose maximale tolérée (DMT) du M6223 en monothérapie (partie 1A) et du M6223 associé au bintrafusp alfa (partie 1B) chez des participants présentant des tumeurs solides métastatiques ou localement avancées non résécables.

Description de l'essai

Primary Outcome:

  • Part 1A and 1B: Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period (28 Days)
  • Part IA and IB: Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events (TRAEs) According to the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) version 5
  • Part IA and IB: Occurrence of Treatment-Emergent Adverse Events (TEAEs) as per Severity and Deaths
  • Part IA and IB: Occurrence of Clinically Significant Change From Baseline in Clinical Laboratory Measures
  • Part IA and IB: Occurrence of Clinically Significant Change From Baseline in Electrocardiogram Findings
  • Part IA and IB: Occurrence of Clinically Significant Change From Baseline in Vital Signs
  • Part IA and IB: Occurrence of Change From Baseline in Eastern Cooperative Oncology Group Performance Status
Secondary Outcome:
  • Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M6223
  • Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
  • Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (τ) (AUCτ) of M6223
  • Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
  • Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
  • Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
  • Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
  • Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
  • Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp alfa
  • Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp alfa
  • Part IA and 1B: Immunogenicity of M6223 Measured by Antidrug Antibody (ADA) Assays
  • Part 1B: Immunogenicity of Bintrafusp alfa Measured by Antidrug Antibody (ADA) Assays
  • Part 1A and 1B: Change from Baseline in QT Interval
  • Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) Assessed as per Investigator
  • Part 1A and 1B: Duration of Response According to Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) Assessed as per Investigator
  • Part 1A and 1B: Time to Tumour Response According to Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) Assessed as per Investigator
  • Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) Assessed as per Investigator
  • Part 1A and 1B: Progression-free Survival Time According to Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) Assessed as per Investigator
  • Part 1A and 1B: Overall Survival

Voir cet essai sur ClinicalTrials.gov

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