Drugs / GRWD5769
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06923761 | May 2023 → Apr 2027 expected | cancer | Grey Wolf Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Grey Wolf Therapeutics | Results Greywolf Therapeutics reports durable clinical responses with first-in-class oral ERAP1 inhibitor GRWD5769 across six solid tumor types greywolftherapeutics.com ↗
First-in-class oral ERAP1 inhibitor demonstrates objective response rates (ORR) of 13–36% across patients with secondary anti-PD-1 resistance or microsatellite stable colorectal cancer without liver metastases in combination with cemiplimab (anti-PD-1) |
| 2025-10-22 | Grey Wolf Therapeutics | Results We won Best Poster at ESMO 2025 greywolftherapeutics.com ↗
In heavily pre-treated patients, we’ve already seen confirmed partial responses (including in MSS colorectal cancer, a notoriously immune-resistant disease) and durable disease control beyond 6 months in multiple patients. |
| 2025-03-04 | Grey Wolf Therapeutics | Results The dawn of antigen modulation greywolftherapeutics.com ↗
Patients' peripheral PBMC samples showed a clear shift in the peptide population and length distribution, with a decrease in 9-mer peptides and an increase in 10–14-mer – exactly the pharmacodynamic pattern expected from ERAP1 inhibition. |
| 2024-06-03 | Grey Wolf Therapeutics | Results Greywolf Therapeutics presents first clinical data for GRWD5769, a first-in-class ERAP1 Inhibitor, at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting greywolftherapeutics.com ↗
The presented data consisted of preliminary findings from the initial repeat dosing monotherapy module of the study and demonstrated well-tolerated dose dependent target engagement following administration of escalating oral doses of GRWD5769. |
| 2023-04-18 | Grey Wolf Therapeutics | Results Promising preclinical data reported at AACR 2023 greywolftherapeutics.com ↗
The study results were featured in an oral presentation (#3467) entitled, “First-in-class inhibitors of ERAP1: Generating antigens as novel targets for MHC1-directed therapies,” at the AACR annual meeting, being held April 14-19, 2023, in Orlando, Florida. |
| 2021-11-12 | Grey Wolf Therapeutics | Results Preclinical data on first-in-class ERAP1 inhibitors presented at SITC greywolftherapeutics.com ↗
New Data Highlight the Potential of Neoantigen-Generating ERAP1 Inhibitors to Drive a Differentiated T Cell Response, Leading to Tumor Growth Inhibition. |
All press releases naming this drug 8 releases
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 | GRWD5769 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06923761 ↗ |
| Route | Intravenous | “Module 2 (GRWD5769 in combination with cemiplimab, administered IV)” NCT06923761 ↗ |