Program 12: Developmental Therapeutics

Dana-Farber Cancer Inst, Boston MA

Investigators

Linked publications & trials

Abstract

Developmental Therapeutics Program Project Summary / Abstract The Developmental Therapeutics (DT) Program comprises a highly collaborative effort across consortium member institutions. It focuses on the earliest phases of bench-to-bedside preclinical and clinical evaluation of promising new anti-cancer drugs from the NCI, from DF/HCC research laboratories, and from industry. Among clinical trials, the Program focuses on disease-agnostic Phase 1 trials, many with expansion cohorts or Phase 2 components that cross cancer types. Strategically, the Program is tightly integrated as a DF/HCC “hub.” On the one hand, it aligns closely with the Center’s basic science Programs in such areas as signal transduction, DNA repair, cell cycle regulation, epigenetics, and immuno-oncology. On the other hand, it partners effectively with DF/HCC’s disease-based Programs: once early evaluation is completed to satisfaction, DT transitions drugs for later phases of development in disease-specific Programs. The Program’s 77 members (30 primary and 47 secondary) represent six DF/HCC institutions and 12 academic departments. In 2019, peer-reviewed grant funding attributed to the Program was $4.6 million in direct costs from the NCI and $0.9 million from other sponsors. During the current funding period, primary DT members published 636 cancer-relevant papers. Of these, 30% were inter-institutional, 9% were intra- programmatic, and 62% were inter-programmatic collaborations between two or more DF/HCC members. This scope of inter-Program interactions reflects DT’s role as a genuine “hub” within the Cancer Center, where the Program also hosts NCI-sponsored U54, UM1, MATCH, and other cooperative agreements for collaborative early drug development. Three Specific Aims are planned over the next CCSG funding period: (1) Design and conduct early phase clinical trials of the most promising new anti-cancer agents and combinations with safety, pharmacokinetic, pharmacodynamic and preliminary efficacy endpoints, with incorporation of biomarkers for drug response, resistance and toxicity; (2) Increase participation of minority and underserved populations in early phase clinical trials; and (3) Provide mentoring and career development support for early career investigators in early drug development. DF/HCC’s extensive infrastructure for transdisciplinary collaboration, clinical trial review and conduct, community engagement, biostatistics, education, and training will be instrumental in achieving these Program goals.