Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

Conditions

• HER2 Expressing Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dose Level 1, VNX-202 — GENETIC
  Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
• Dose Level 2, VNX-202 — GENETIC
  Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
• Dose Level 3, VNX-202 — GENETIC
  Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
• Dose Level 4, VNX-202 — GENETIC
  Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

Study Details

This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.

Key Dates

Start date

Nov 18, 2025

Status verified

May 2026

Primary completion

Sep 30, 2033

Completion

Oct 31, 2033

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1/Group 2/Group 3/Group 4

Primary Outcome Measure

Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) [ Time Frame: Change from Baseline to Year 5 post dosing ]

Central Contacts

• Allen Reha
  908-938-6019
  [email protected]

Locations (6)

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