# FDA018-ADC

Source: https://onco.cc/drugs/fda018-adc/  
OnCo record `fda018-adc` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

FDA018-ADC, also called F0024, is an experimental drug that carries chemotherapy to TROP2-bearing cells. Early response results do not establish a benefit over standard treatment.

## Summary

NCT05174637 identifies F0024 as an alternative name for FDA018-ADC. ASCO 2024 abstract e13131 reports 62 treated patients at the October 8, 2023 cutoff. At 10 mg/kg, 11/29 efficacy-evaluable TNBC patients had partial responses (ORR 37.9%, 95% CI 20.7 to 57.7). Grade 3 or higher treatment-related adverse events occurred in 32/62 patients (51.6%), including grade 3 neutropenia in 45.2%. The selected dose cohort is not a randomized efficacy comparison. Later phase 3 registration is separate from this first-in-human evidence.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-10-06
- Also known as: F0024; FDA018-Antibody-drug Conjugate
- Tags: pipeline; ctgov-ingest
- Code: FDA018
- Modality: ADC
- Mechanism: TROP2-directed ADC delivering SN-38, the active metabolite of irinotecan.
- Payload: SN-38 (TOP1 inhibitor)

## Sources

- Publisher abstract: https://doi.org/10.1200/jco.2024.42.16_suppl.e13131
- ClinicalTrials.gov NCT05174637: https://clinicaltrials.gov/study/NCT05174637

## Connected records

- cancers: [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- institutions: [Fudan University Shanghai Cancer Center](https://onco.cc/institutions/fuscc/)
- trials: [A Study of FDA018-ADC in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05174637/), [FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer](https://onco.cc/trials/nct06519370/)

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