NCT05901285

Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Vaxiion Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.

Detailed description

This study will evaluate the safety and tolerability of VAX014 using a 3+3 dose escalation design to determine a maximum tolerated dose (MTD) or maximum practical dose (MPD) of single agent VAX014. The DLT assessment period will be the initial 21-days of injections. Subjects will receive weekly injections for the initial 8 weeks. Up to six dose levels will be evaluated (i.e., \[starting dose\], \[starting dose\] x 3, \[starting dose\] x 10, \[starting dose\] x 30, \[starting dose\] x 100, \[starting dose\] x 300). Subjects may continue on treatment following discussion between the Principal Investigator and Sponsor/Medical Monitor. After the determination of a single agent RP2D by the SRC for single agent intratumoral VAX014, an Expansion Phase will be conducted combining intratumoral VAX014 with Investigator's choice of nivolumab or pembrolizumab. The SRC may adjust the RP2D of VAX014 used during the Expansion Phase based on accumulating safety data. The Expansion Phase will consist of up to 25 subjects. For the first 3 subjects treated with the combination of VAX014 and either nivolumab or pembrolizumab, the initial 2 doses of intratumoral VAX014 will be reduced by one dose level from the VAX014 RP2D. If the initial 3 subjects are able to escalate to the RP2D for VAX014, all subsequent subjects will then receive VAX014 at the RP2D starting with the first dose of VAX014.

Conditions

• Advanced Solid Tumor
• Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab

Interventions

Type	Name	Description
DRUG	VAX014	Intratumorally administered oncolytic agent comprised of recombinant bacterial minicells. VAX014 is not infectious and is not capable of replication
COMBINATION_PRODUCT	Nivolumab or pembrolizumab	VAX014 will be given in combination with Investigator's choice of nivolumab or pembrolizumab.

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2023-06-13
• Last updated: 2025-11-25

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study