Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03)

Titre officiel

A Phase 1b/2 Multicentre, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2 Overexpressing Gastric Cancer (DESTINY-Gastric03)

Sommaire:

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumour activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or durvalumab in HER2-positive advanced/metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or durvalumab administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumour efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-positive gastric/GEJ cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Description de l'essai

Primary Outcome:

  • Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
  • Part 2: Objective Response Rate (ORR)
Secondary Outcome:
  • Part 1: Objective Response Rate (ORR)
  • Part 2: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
  • Duration of Response (DoR)
  • Disease Control Rate (DCR)
  • Progression Free Survival (PFS)
  • Overall survival (OS)
  • Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms
  • Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab
  • Presence of ADAs for T-DXd and durvalumab (in study arms including T-DXd and durvalumab)

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer