A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 03 Mar 2025

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At a glance

Drugs IVX 037 (Primary) ; Sintilimab
Indications Adenocarcinoma; Colorectal cancer; Gastric cancer; Oesophageal cancer; Ovarian cancer; Solid tumours
Focus Adverse reactions; Therapeutic Use
Sponsors ImmVirX

26 Aug 2024 Planned number of patients changed from 40 to 70.
26 Aug 2024 Protocol has been amended to add phase 1a IVX037 montherqpy and Phase 1b cohort of IVX037 with checkpoint inhibitor, sintilimab, interventions changed from single group assignment to sequential assignment, treatment arms were changed to include 2arms part 1a and 1b and hence the patient number has also changes to 70 and endpoints were changed from safety to safety and efficacy.
26 Aug 2024 Planned End Date changed from 1 Sep 2024 to 30 Nov 2026.

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