BETA prime : a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors
© 2023. The Author(s)..
AdAPT-001 is an oncolytic adenovirus (OAV) with a transforming growth factor beta (TGF-ß) trap, which neutralizes the immunosuppressive and profibrotic cytokine, TGF-ß. The aim or purpose of this phase 1 study was to assess the safety and tolerability and, secondarily, the efficacy of AdAPT-001 after single intratumoral injection (IT) (Part 1) and multidose IT injection (Part 2) in patients with superficially accessible, advanced refractory solid tumors. Part 1 enrolled 9 patients with a 3 + 3 single dose-escalation safety run-in involving 2.5 × 1011, 5.0 × 1011, 1.0 × 1012 viral particles (vps). No dose-limiting toxicities or treatment-related serious adverse events (SAEs) were seen. In Part 2, a dose-expansion phase, 19 patients received AdAPT-001 at 1.0 × 1012 vps until disease progression according to Response Evaluation Criteria in Solid Tumors or RECIST 1.1. The overall responses to treatment included confirmed partial responses (3), durable stable disease ≥ 6 months (5), and progressive disease (13). AdAPT-001 is well tolerated. Evidence of an anti-tumor effect was seen in both injected and uninjected lesions. The recommended Phase 2 dose was 1.0 × 1012 vp administered by intratumoral injection once every 2 weeks. Combination of AdAPT-001 with a checkpoint inhibition is enrolling.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:31 |
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| Enthalten in: |
Cancer gene therapy - 31(2024), 4 vom: 11. Apr., Seite 517-526 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Conley, Anthony P [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 16.04.2024 Date Revised 25.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1038/s41417-023-00720-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a AdAPT-001 is an oncolytic adenovirus (OAV) with a transforming growth factor beta (TGF-ß) trap, which neutralizes the immunosuppressive and profibrotic cytokine, TGF-ß. The aim or purpose of this phase 1 study was to assess the safety and tolerability and, secondarily, the efficacy of AdAPT-001 after single intratumoral injection (IT) (Part 1) and multidose IT injection (Part 2) in patients with superficially accessible, advanced refractory solid tumors. Part 1 enrolled 9 patients with a 3 + 3 single dose-escalation safety run-in involving 2.5 × 1011, 5.0 × 1011, 1.0 × 1012 viral particles (vps). No dose-limiting toxicities or treatment-related serious adverse events (SAEs) were seen. In Part 2, a dose-expansion phase, 19 patients received AdAPT-001 at 1.0 × 1012 vps until disease progression according to Response Evaluation Criteria in Solid Tumors or RECIST 1.1. The overall responses to treatment included confirmed partial responses (3), durable stable disease ≥ 6 months (5), and progressive disease (13). AdAPT-001 is well tolerated. Evidence of an anti-tumor effect was seen in both injected and uninjected lesions. The recommended Phase 2 dose was 1.0 × 1012 vp administered by intratumoral injection once every 2 weeks. Combination of AdAPT-001 with a checkpoint inhibition is enrolling | ||
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| 700 | 1 | |a Bessudo, Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Gastman, Brian R |e verfasserin |4 aut | |
| 700 | 1 | |a Villaflor, Victoria M |e verfasserin |4 aut | |
| 700 | 1 | |a Larson, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Reid, Tony R |e verfasserin |4 aut | |
| 700 | 1 | |a Caroen, Scott |e verfasserin |4 aut | |
| 700 | 1 | |a Oronsky, Bryan |e verfasserin |4 aut | |
| 700 | 1 | |a Stirn, Meaghan |e verfasserin |4 aut | |
| 700 | 1 | |a Williams, Jeannie |e verfasserin |4 aut | |
| 700 | 1 | |a Burbano, Erica |e verfasserin |4 aut | |
| 700 | 1 | |a Coyle, Angelique |e verfasserin |4 aut | |
| 700 | 1 | |a Barve, Minal A |e verfasserin |4 aut | |
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| 700 | 1 | |a Abrouk, Nacer |e verfasserin |4 aut | |
| 700 | 1 | |a Kesari, Santosh |e verfasserin |4 aut | |
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