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NCT05485974
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
Phase 1 trial testing HBI-2438 in Lung Cancer in 44 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | HUYABIO International, LLC. |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 August 2022 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 14 locations across Puerto Rico, United States |
Drugs / interventions tested
- HBI-2438 — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Cancer of Pancreas — all drugs for Cancer of Pancreas →
Sponsor
HUYABIO International, LLC. — full company profile →
Who can join
18 and older, any sex, with Lung Cancer or Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting <i>KRAS</i> G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver.
Ros J, Vaghi C, Baraibar I, Saoudi González N, et al · · 2024 · cited 35× · PMID 38542278 · DOI 10.3390/ijms25063304 -
Next-generation therapies for pancreatic cancer.
Buckley CW, O'Reilly EM. · · 2024 · cited 33× · PMID 38415709 · DOI 10.1080/17474124.2024.2322648 -
The Therapeutic Landscape for <i>KRAS</i>-Mutated Colorectal Cancers.
Tria SM, Burge ME, Whitehall VLJ. · · 2023 · cited 33× · PMID 37190303 · DOI 10.3390/cancers15082375 -
Targeting KRAS in Pancreatic Ductal Adenocarcinoma: The Long Road to Cure.
de Jesus VHF, Mathias-Machado MC, de Farias JPF, Aruquipa MPS, et al · · 2023 · cited 28× · PMID 37894382 · DOI 10.3390/cancers15205015 -
The current landscape of using direct inhibitors to target KRAS<sup>G12C</sup>-mutated NSCLC.
Batrash F, Kutmah M, Zhang J. · · 2023 · cited 27× · PMID 37925476 · DOI 10.1186/s40164-023-00453-8 -
Targeting KRAS mutations in pancreatic cancer: opportunities for future strategies.
Linehan A, O'Reilly M, McDermott R, O'Kane GM. · · 2024 · cited 24× · PMID 38576709 · DOI 10.3389/fmed.2024.1369136 -
Inhibition of the RAF/MEK/ERK Signaling Cascade in Pancreatic Cancer: Recent Advances and Future Perspectives.
Adamopoulos C, Cave DD, Papavassiliou AG, Papavassiliou AG. · · 2024 · cited 19× · PMID 38338909 · DOI 10.3390/ijms25031631 -
Response and Resistance to RAS Inhibition in Cancer.
Ebright RY, Dilly J, Shaw AT, Aguirre AJ. · · 2025 · cited 16× · PMID 40293709 · DOI 10.1158/2159-8290.cd-25-0349
Verify or expand the search:
- PubMed search for NCT05485974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other HUYABIO International, LLC. trials
Trials by the same sponsor.
- NCT05141357 — A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer · Phase 2 · terminated
- NCT05163028 — A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations · Phase 1 · active not recruiting
- NCT04680026 — A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) · Phase 2 · active not recruiting
- NCT04650542 — Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects · Phase 1 · completed
- NCT03397641 — A Phase 1 Study of HBI-3000 · Phase 1 · 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 NCT05485974 (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 HUYABIO International, LLC.
- Last refreshed: 24 September 2025
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/NCT05485974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing