---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-074995"
form_type: "8-K"
ticker: "BDTX"
cik: "0001701541"
company_name: "Black Diamond Therapeutics, Inc."
filed_at: "2023-06-27T23:59:59+00:00"
generated_at: "2026-06-13T16:23:42.125485+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BDTX-1535 shows 5/12 NSCLC patients with confirmed partial response; expansion cohorts planned

## Summary
- 5 of 12 evaluable NSCLC patients achieved confirmed partial response per RECIST 1.1; 1 unconfirmed PR, 6 stable disease.
- No dose-limiting toxicity at 15-200 mg QD; DLTs observed at 300 mg (1/15) and 400 mg (5/12).
- Enrollment to start at 200 mg QD in two NSCLC expansion cohorts targeting acquired resistance and intrinsic driver mutations.
- FDA meeting planned in H2 2023 to discuss dosing strategy and potential accelerated approval path.
- Phase 1 GBM dose escalation update expected in Q4 2023.

## SEC filing metadata
- accession: 0001104659-23-074995
- form_type: 8-K
- ticker: BDTX
- cik: 0001701541
- company_name: Black Diamond Therapeutics, Inc.
- filed_at: 2023-06-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701541/000110465923074995/0001104659-23-074995-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701541/000110465923074995/tm2319750d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-074995
- JSON: https://secwatch.observer/filing/0001104659-23-074995.json
- Plain text: https://secwatch.observer/filing/0001104659-23-074995.txt

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