Investigational Drug Branch (IDB)

IDB oversees an innovative early therapeutics clinical research program.

IDB collaborates with academia and industry through an NCI-funded program to carry out the clinical evaluation of novel anti-cancer agents.

Two programs run in sequence to manage a portfolio of partnerships between NCI and Pharma:

• NExT is the program in the NCI Developmental Therapeutics Program that selects agents for NCI-sponsored pre-clinical and clinical development
• The Experimental Therapeutics Clinical Trials Network (ETCTN) is the clinical trials network administered through the IDB that performs clinical studies of the agents that are approved through NExT. Dr. Percy Ivy is the Program Director for the ETCTN and Kim Witherspoon is the Senior Program Specialist.

In these partnerships, NCI:

• Assumes the regulatory responsibility for the ETCTN clinical trials (IND holder)
• Sponsors clinical trials to advance the development of these NCI-IND agents in the ETCTN.

IDB physicians:

• Work with ETCTN investigators and pharma partners to formulate the clinical development plans for NCI-IND agents, including review and prioritization of clinical trial proposals (Letter of Intent (LOI))
• Monitor ETCTN clinical trials for safety and efficacy
• Investigate and prepare reports concerning adverse events (AEs) for the NCI-IND agents.
• Work closely with the Investigational Drug Steering Committee and its Task Forces to increase the transparency and openness of the trial design and prioritization process

IDB is comprised of the following Sections and agent portfolios:

Section	Portfolios
Investigational Therapeutics I	Angiogenesis (VEGFR2; Bruton's Tyrosine Kinase); cell cycle/p53 (CDK, mdm2); cell death (Bcl2, BCL-XL); DNA repair and DNA damage response (PARP, BER, WEE1, ATM, ATR, DNA-PK, RNR); radiopharmaceuticals and radiosensitizers; stem cell signaling pathways (Hedgehog, Notch)
Investigational Therapeutics II	PI3 kinase/AKT/mTOR inhibitors; protein homeostasis inhibitors; cell cycle agents; microtubule inhibitors; MET and ALK inhibitors; epigenetic therapies
Investigational Therapeutics III	Immunotherapies including checkpoint inhibitors, T-cell stimulators, cytokines, vaccines, Imids, oncolytic virus, T-cell engaging bispecific antibodies; antibodies and antibody drug conjugates; signal transduction pathway inhibitors targeting Ras/Raf/Mek/Erk, Her-2, EGFR, IGF-1R

For academic investigators with new clinical trial proposals interested in submitting an unsolicited LOI, please contact the IDB physician in charge of the appropriate drug portfolio for further discussions. This step will help to ensure the proposed LOI will not be duplicative and is written in an effective manner that will increase its likelihood of acceptance and funding by CTEP. The IDB physicians assigned to each agent can be found under CTEP Agents and Active Agreements.

IDB staff also have leadership roles in three Cancer Moonshot programs.

PDXNet is a network of four PDX Development and Trial Centers(U54) and one PDXNet Data Commons and Coordinating Center (U24) focusing on preclinical research on NCI-IND agents in PDX models to lead to clinical translation in the ETCTN. Dr. Jeff Moscow is the Program Director and Kim Witherspoon is the Senior Program Specialist.

The Drug Resistance and Sensitivity Network (DRSN) is a network of four Drug Resistance and Sensitivity Centers (U54) that examine issues in drug resistance and drug sensitivity that can lead to clinical translation in the ETCTN as well as in other clinical trials. Dr. Austin Doyle is the Program Director and Kim Witherspoon is the Senior Program Specialist.

The network of four Cancer Immune Monitoring and Analysis Centers (CIMACs; U24) and one Cancer Immunologic Data Commons (CIDC; U24) is creating a national resource for providing validated, standardized and harmonized biomarker assays for national clinical trials. Dr. Helen Chen is Co-Leader of this effort and Dr. Min Song is a Program Director.