# VICKtOrY Early Clinical Trials Consortium

> **NIH NIH UM1** · YALE UNIVERSITY · 2023 · $2,044,455

## Abstract

The new era in cancer drug development represents a paradigm shift in how early phase studies are conducted
relative to the “conventional” approach of treating without consideration to underlying tumor genomics, biology 
and immunology. Translational endpoints, including levels of target expression, engagement, and modulation 
of downstream effectors are being assessed as early as possible, and increasing emphasis is being placed on 
early patient selection, utilizing novel biomarker assays and molecular characterization to identify patients most 
likely to respond. The ultimate purpose of the NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) 
is to develop new therapeutic options while also defining better approaches for the development of novel 
anticancer agents that capitalize on the ability to characterize tumors molecularly and by also finding appropriate 
biomarkers to select patients most likely to respond. As biomarker-driven trials become the cornerstone of early 
phase investigation, allowing for the study of potential mechanisms of response and resistance, incorporation 
of these biomarkers is lending itself to novel trial designs which incorporate fewer, and often rarer patient 
subsets, defining greater patient outcomes with smaller recruited populations. As a result, a unique network 
such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of 
expertise, is needed. The ETCTN allows investigators to test relevant bench-to-bedside findings, and through 
integrated analysis and the development of interdisciplinary teams, incorporates reverse translation to bring the 
bedside back to the bench. This application is a re-competition of our previous ETCTN UM1 award 
(1UM1CA186689), demonstrating both our progress over the past funding period as well as our capabilities to 
conduct early phase clinical trials. We have slightly amended our original partnerships which now include 
Vanderbilt-Ingram, University of California San Diego, Karmanos Cancer Institute, University of Oklahoma 
Stephenson Cancer Center (new) and the Yale Cancer Center (VICKtOrY). Our team aims to 1) leverage novel 
scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, 
common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging 
biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career 
investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical 
research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial 
recruitment, no less than 10% underserved/special populations. The members of our team have a unique set 
of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the 
next generation of cancer investigators....

## Key facts

- **NIH application ID:** 10784848
- **Project number:** 4UM1CA186689-07
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Patricia M. LoRusso
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $2,044,455
- **Award type:** 4N
- **Project period:** 2014-07-10 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10784848

## Citation

> US National Institutes of Health, RePORTER application 10784848, VICKtOrY Early Clinical Trials Consortium (4UM1CA186689-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10784848. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
