---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-115679"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2022-11-08T23:59:59+00:00"
generated_at: "2026-06-22T04:13:18.815362+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BT8009 Phase II expansion first patient dosed; Phase I dose escalation complete

## Summary
- Phase I dose escalation complete; RP2Ds: 5 mg/m2 weekly and 7.5 mg/m2 (2 on, 1 off) selected.
- Confirmed RECIST responses in UC and NSCLC; median duration of response not yet reached.
- First patient dosed in Phase II expansion; includes cohorts evaluating BT8009 with CPI.
- Priority indication: first-line metastatic UC in cisplatin-ineligible patients combined with CPI.
- Updated Phase I data from 49 patients to be presented at medical meeting in 1H 2023.

## SEC filing metadata
- accession: 0001104659-22-115679
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2022-11-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465922115679/0001104659-22-115679-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465922115679/tm2229927d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-115679
- JSON: https://secwatch.observer/filing/0001104659-22-115679.json
- Plain text: https://secwatch.observer/filing/0001104659-22-115679.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.