# 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 is an experimental antibody-drug conjugate from Shanghai Fudan-Zhangjiang Bio-Pharmaceutical in phase 3 trials for triple-negative breast cancer, with its target not yet stated publicly.

## Summary

FDA018-ADC (FDA018) is an antibody-drug conjugate developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06519370 (FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer), in triple-negative breast cancer. The largest, NCT06519370, plans to enrol 350 participants with primary completion was scheduled for 2026-08-18 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Also known as: FDA018-Antibody-drug Conjugate
- Tags: pipeline; ctgov-ingest
- Code: FDA018
- Modality: ADC
- Mechanism: Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.

## Sources

- ClinicalTrials.gov: trials of FDA018-ADC: https://clinicaltrials.gov/search?intr=FDA018

## Connected records

- cancers: [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- institutions: [Fudan University Shanghai Cancer Center](https://onco.cc/institutions/fuscc/)
- trials: [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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