Last reviewed · How we verify
NCT05730673
Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer
Phase 2 trial testing 700mg leronlimab weekly dose in CCR5. Withdrawn.
27 May 2023
Quick facts
| Lead sponsor | CytoDyn, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 September 2022 |
| Primary completion | 27 May 2023 |
| Estimated completion | 10 August 2023 |
Drugs / interventions tested
- 700mg leronlimab weekly dose — full drug profile →
- 80mg Regorafenib at week 1 — full drug profile →
- 120mg Regorafenib at week2 — full drug profile →
- 160 mg Regorafenib at week 3 — full drug profile →
Conditions studied
- CCR5 — all drugs for CCR5 →
- Microsatellite Stable — all drugs for Microsatellite Stable →
- Metastatic — all drugs for Metastatic →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
CytoDyn, Inc. — full company profile →
Who can join
18 and older, any sex, with CCR5 or Microsatellite Stable. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
Verify or expand the search:
- PubMed search for NCT05730673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other CytoDyn, Inc. trials
Trials by the same sponsor.
- NCT04678830 — Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 · Phase 2 · completed
- NCT04521114 — Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis · Phase 2 · completed
- NCT04504942 — Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors · Phase 2 · completed
- NCT04347239 — Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 · Phase 2 · completed
- NCT04343651 — Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05730673 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CytoDyn, Inc.
- Last refreshed: 17 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05730673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing