Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumours

Titre officiel

A Phase 1/2a, Multicentre, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumours

Sommaire:

Déterminer la dose recommandée pour la phase II (DRP2) de TBio-6517, administré par injection directe dans les tumeurs ou par voie intraveineuse, en association avec le pembrolizumab, chez des patients présentant des tumeurs solides (RIVAL-01).

Description de l'essai

Primary Outcome:

  • Incidence of adverse events when TBio-6517 administered by direct injection into tumour(s) alone at each dose level
  • Incidence of adverse events when TBio-6517 administered by direct injection into tumour(s) when combined with pembrolizumab
  • Maximum tolerated dose (MTD) or Maximum feasible dose (MFD) and determination of the recommended Phase 2 dose (RP2D) of TBio-6517 alone and in combination with pembrolizumab.
  • Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D
  • Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D
Secondary Outcome:
  • Number and severity of adverse events at the RP2D
  • Median overall survival (OS)
  • Median Duration of Response (DoR)
  • Proportion of patients with a response (ORR)
  • Median Disease Control Rate (DCR)
  • Time to tumour progression (TTP)
  • Median progression free survival

This is a Phase 1/2a dose escalation study with TBio-6517 administered by direct injection into tumour(s) or by intravenous infusion. The Phase 1 portion has 4 arms; the first arm (Arm A) will determine the RP2D of TBio-6517 alone when directly injected into tumour(s), and the second arm (Arm B) will determine the RP2D of TBio-6517 when combined with pembrolizumab. The third and fourth arms will determine the RP2D of TBio-6517 when given intravenously alone and with pembrolizumab, respectively.

In the Phase 2a portion, the clinical benefit of TBio-6517 combined with pembrolizumab will be further explored in patients with Microsatellite Stable Colorectal Cancer (MSS-CRC), Cholangiocarcinoma (CCA), Cutaneous Melanoma, and Cutaneous Squamous Cell Carcinoma of the Skin (cSCC), as assessed by overall response rate (ORR) from central radiology review.

Voir cet essai sur ClinicalTrials.gov

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