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Clinical Trial
. 2024 Apr;31(4):517-526.
doi: 10.1038/s41417-023-00720-0. Epub 2023 Dec 25.

BETA prime: a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors

Anthony P Conley  1 , Christina L Roland  1 , Alberto Bessudo  2 , Brian R Gastman  3 , Victoria M Villaflor  4 , Christopher Larson  5 , Tony R Reid  5 , Scott Caroen  5 , Bryan Oronsky  6 , Meaghan Stirn  5 , Jeannie Williams  5 , Erica Burbano  5 , Angelique Coyle  5 , Minal A Barve  7 , Naveed Wagle  8 , Nacer Abrouk  9 , Santosh Kesari  8
Affiliations
Clinical Trial

BETA prime: a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors

Anthony P Conley et al. Cancer Gene Ther. 2024 Apr.

Abstract

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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Conflict of interest statement

CL, TRR, SC, BO, MS, JW, EB, and AC report employment with and ownership of EpicentRx Inc. stock. No disclosures were reported by the other authors.

Figures

Fig. 1
Fig. 1. Anti-tumor activity of AdAPT-001 from Part 1 of the study.
A Tumor diameter % change from screening, part 1 straight line graph. B Tumor activity descriptive statistics, part 1 bar plot. C Tumor response by cohort, part 1 bar plot.
Fig. 2
Fig. 2. Anti-tumor activity of AdAPT-001 from Part 2 of the study.
A Tumor diameter waterplot part 2. B Tumor activity swimmer’s plot with a dotted line at 6 months to indicate prolonged stability.
Fig. 3
Fig. 3. Three individual patient examples of AdAPT-001-mediated anti-tumor activity.
A Chordoma patient treated with AdAPT-001, response in injected lesion. B Response of back heel lesions to AdAPT-001 over time with lesion disappearance. C Partial response of patient with thyroid carcinoma charted over time.
Fig. 4
Fig. 4. Serum adenovirus levels in patient 001-006.
Serum levels fell to below the limit of quantification 1 day after injection (less than 190 copies/mL, plotted as 95) and increased at 7 days after injection.
See this image and copyright information in PMC

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