# A phase 0 fund to test academic compounds in humans with microdoses and imaging

Source: https://onco.cc/ideas/idea-fund-phase-zero-fund/  
OnCo record `idea-fund-phase-zero-fund` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Before investing in a full trial, give a few patients a tiny dose of a new compound and use scans and blood tests to see whether it reaches the tumour and hits its target. Fund these small studies as a matter of routine.

## Summary

Phase 0 (exploratory IND) studies use microdoses or short courses to measure pharmacokinetics, target engagement (via PET tracers, tumour biopsies or pharmacodynamic markers) and biodistribution before committing to IND-enabling toxicology at full scale. They are cheap, fast and answer the question that kills most academic compounds late: does it get where it needs to go and do what it should in people? A dedicated fund pays for radiolabelling, tracer synthesis, phase 0 unit costs and biopsy-based pharmacodynamics for academic assets, with a rule that assets failing target engagement are dropped and published.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Routing academic candidates through funded phase 0 studies kills at least 30% before IND-enabling investment and raises the phase 2 success rate of those that proceed compared with the historical academic pipeline, at a cost per candidate under $1 million.
- Rationale: Regulatory frameworks for exploratory INDs exist in the US and EU; the NCI ran a phase 0 programme demonstrating feasibility with a PARP inhibitor. Immuno-PET and radiolabelled small molecules now allow direct measurement of tumour delivery for many modalities, including antibodies and ADCs.
- Proposed test: Fund phase 0 studies for ten academic assets and compare downstream attrition and cost with a matched historical cohort that went straight to IND-enabling work.
- Maturity: early-clinical
- Actor: research

## Sources

- Bottleneck evidence (The valley of death between lab and product): Butler, Translational research: crossing the valley of death (Nature 2008): https://doi.org/10.1038/453840a

## Connected records

- ideas: [A fast IND-enabling fund that pays for toxicology and manufacturing in eight weeks](https://onco.cc/ideas/idea-fund-ind-enabling-fund/), [A university cyclotron network with shared regulatory files for new tracers](https://onco.cc/ideas/idea-fund-academic-radiopharma-pipeline/), [Forty-eight-hour small grants for bold experiments in neglected cancers](https://onco.cc/ideas/idea-fund-fast-grants-oncology/)
- technologies: [Immuno-PET](https://onco.cc/technologies/immuno-pet/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [PET (positron emission tomography)](https://onco.cc/technologies/pet/)
- terms: [Standardised uptake value (SUV)](https://onco.cc/terms/suv/)
- bottlenecks: [Lab models that fail to predict what happens in patients](https://onco.cc/bottlenecks/b-preclinical-models/), [The valley of death between lab and product](https://onco.cc/bottlenecks/b-translational-valley/)
- key papers: [Translational research: crossing the valley of death](https://onco.cc/key-papers/paper-butler-nature/)

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