# A randomized, sequential dose escalation study comparing open-label T2307 to standard of care in candidemia due to Candida auris or other drug-resistant Candida species: A phase 2/3 adaptive design

> **NIH NIH R34** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2020 · $222,750

## Abstract

Project Summary/Abstract
This study will examine the safety and efficacy of a novel antifungal compound, T2307,
in a Phase II dose-escalation cohort design, international clinical trial of patients with
candidemia due to C. auris and other antifungal-resistant (AFR) Candida species. This
multi-center, international trial will be conducted by a carefully selected network of sites,
defined by the PI as being characterized as having experience in studying invasive
candidiasis, sufficient institutional support, ability to identify Candida to species level in
a timely manner using automated technology, and demonstrate sufficient incidence of
clinically relevant infections due to target organisms (C. auris and other AFR Candida)
to successfully conduct the trial.
Sites will be determined in a real-time manner, as emerging trends in incidence and
prevalence are reviewed by our consultants and leading public health officials.
Underrepresented populations and highly affected populations will be afforded careful
attention to encourage inclusion.
We will design a Phase II dose-finding clinical trial that will seamlessly evolve into a
randomized Phase III trial. We will identify participating sites, determine feasibility,
develop a clinical specimen repository, develop SOPs, provide for human subject
protections, develop a database, source documents and electronic case report forms,
develop monitoring plans, training materials, determine eligibility and exclusion criteria.
We will establish a Data Safety Monitoring Board (DSMB) and Data Review Committee
(DRC) with defined roles to review safety procedures, to confirm outcomes and validate
dose progression and ultimately allow the safe transition to the Phase III design.

## Key facts

- **NIH application ID:** 9929388
- **Project number:** 1R34AI150517-01
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Peter George Pappas
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $222,750
- **Award type:** 1
- **Project period:** 2020-09-03 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9929388

## Citation

> US National Institutes of Health, RePORTER application 9929388, A randomized, sequential dose escalation study comparing open-label T2307 to standard of care in candidemia due to Candida auris or other drug-resistant Candida species: A phase 2/3 adaptive design (1R34AI150517-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9929388. Licensed CC0.

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