Drugs / TT125-802
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06403436 | Nov 2023 → Jun 2026 | non-small cell lung carcinoma, squamous cell lung carcinoma | TOLREMO therapeutics AG | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | TOLREMO therapeutics AG | Results TOLREMO therapeutics Completes Phase I Study of TT125-802 and Presents Final Clinical Data at World Conference on Lung Cancer 2026 tolremo.com ↗
Final Phase 1 data provide clinical validation of CBP/p300 as a novel therapeutic target for overcoming transcriptional resistance in NSCLC |
| 2025-10-17 | TOLREMO therapeutics AG | Results TOLREMO therapeutics Completes First In Human Dose Escalation for TT125-802 and Presents Solid Tumor Monotherapy Results at ESMO 2025 tolremo.com ↗
TOLREMO therapeutics AG (TOLREMO) today announced encouraging clinical data from 34 patients with advanced solid tumors treated with TT125-802 in the dose escalation part of an ongoing first-in-human study ( NCT06403436 ). |
| 2025-08-28 | TOLREMO therapeutics AG | Regulatory TOLREMO therapeutics Receives Two FDA Fast Track Designations for TT125-802 in Pretreated, Advanced or Metastatic NSCLC With Either an EGFR or a KRAS-G12C Mutation tolremo.com ↗
Basel, August 28, 2025 – TOLREMO therapeutics AG (TOLREMO) , today announced that their lead candidate, TT125-802, received two Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC). |
| 2025-06-04 | TOLREMO therapeutics AG | Results TOLREMO therapeutics Announces TT125-802 is the First CBP/p300 Bromodomain Inhibitor to Show Clinical Activity in Solid Tumors tolremo.com ↗
To date TT125-802 shows impressive anti-tumor activity in advanced solid tumors, including deep and durable responses in non-small cell lung cancer (NSCLC). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | TOLREMO therapeutics AG | TOLREMO therapeutics Completes Phase I Study of TT125-802 and Presents Final Clinical Data at World Conference on Lung Cancer 2026 tolremo.com ↗ |
| 2025-10-17 | TOLREMO therapeutics AG | TOLREMO therapeutics Completes First In Human Dose Escalation for TT125-802 and Presents Solid Tumor Monotherapy Results at ESMO 2025 tolremo.com ↗ |
| 2025-08-28 | TOLREMO therapeutics AG | TOLREMO therapeutics Receives Two FDA Fast Track Designations for TT125-802 in Pretreated, Advanced or Metastatic NSCLC With Either an EGFR or a KRAS-G12C Mutation tolremo.com ↗ |
| 2025-06-04 | TOLREMO therapeutics AG | TOLREMO therapeutics Announces TT125-802 is the First CBP/p300 Bromodomain Inhibitor to Show Clinical Activity in Solid Tumors tolremo.com ↗ |
| 2023-11-28 | TOLREMO therapeutics AG | TOLREMO Treats First Patient in Phase I Trial with TT125-802, a Novel Therapeutic Agent to Overcome Transcriptional Cancer Drug Resistance tolremo.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TT125-802 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06403436 ↗ |
| Route | Oral | “TT125-802 administered orally” NCT06403436 ↗ |