# Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN

> **NIH NIH UM1** · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · 2020 · $5,651,467

## Abstract

PROJECT SUMMARY
As the California Cancer Consortium (CCC), four National Cancer Institute (NCI)-Designated Cancer Centers
propose to participate in the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) to conduct early
phase clinical trials of experimental therapeutics. The CCC comprises City of Hope (COH, Lead Academic
Organization [LAO]), the University of Southern California (USC, Affiliated Organization [AO]), the University of
California, Davis (UCD, AO), and Stanford Cancer Institute (SCI, AO), and has a 25-year history as a
multidisciplinary group conducting early phase clinical trials of NCI-sponsored investigational new drugs under
previous U01 and UM1 Cooperative Agreements and N01 Contracts. Our multidisciplinary group of investigators
will contribute to ETCTN Project Teams by leveraging the combined expertise of COH, UCD, USC, and SCI in
molecular pharmacology, pharmacokinetics, pharmacodynamics, pharmacogenomics, signal transduction, cell
cycle regulation, non-invasive imaging, and bioinformatics to conduct innovative, laboratory-directed early phase
developmental and pharmacokinetic studies. We propose to use the combined patient and scientific resources
and expertise of UCD, COH, USC, and SCI to accomplish the following Specific Aims: (Aim 1) to use the
existing relevant capabilities and scientific leadership of the CCC to enhance the ETCTN program; (Aim 2) to
leverage the combined breadth of the clinical programs at COH, USC, UCD, and SCI NCI-Designated
Comprehensive Cancer Centers to support the rapid completion of ETCTN trials; (Aim 3) to use the central Data
Coordinating Center (DCC) and Biostatistics Core (BC) at COH to facilitate frequent communication within the
CCC and with the NCI and ETCTN, provide rapid development and effective oversight of trials, and ensure
adherence to policies and procedures; and (Aim 4) to optimize information gained from ETCTN clinical trials by
including molecular characterization of patients' malignancies and incorporating molecular pharmacodynamic
endpoints and investigational imaging. These early phase studies will lead to recommended, biologically effective
doses, greater understanding of the spectrum of normal tissue toxicity of agents, and initial estimates of efficacy.
They will also provide mechanistic validation of the effects of the agents on critical tumor cell targets, correlate
drug-related changes in tumor and host biologic markers with clinical outcome, and develop new insights into
the therapeutic mechanisms of action of the compounds both in the laboratory and the clinic. As such, they will
advance the ETCTN's overall goal of accelerating the development of novel anticancer agents that capitalize on
unique molecular features of individual tumors and identifying appropriate biomarkers to select patients who are
most likely to respond to specific agents.

## Key facts

- **NIH application ID:** 9933722
- **Project number:** 2UM1CA186717-06
- **Recipient organization:** BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
- **Principal Investigator:** A. Dimitrios Colevas
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $5,651,467
- **Award type:** 2
- **Project period:** 2014-03-28 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9933722

## Citation

> US National Institutes of Health, RePORTER application 9933722, Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN (2UM1CA186717-06). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9933722. Licensed CC0.

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