Last reviewed · How we verify
NCT05163028
A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations
Phase 1 trial testing HBI-2376 in Non Small Cell Lung Cancer in 42 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 | 42 |
| Start date | 13 December 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 12 locations across Puerto Rico, United States |
Drugs / interventions tested
- HBI-2376 — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
HUYABIO International, LLC. — full company profile →
Who can join
18 and older, any sex, with Non Small Cell Lung Cancer or Colorectal 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 or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819 -
SHP2: A Pleiotropic Target at the Interface of Cancer and Its Microenvironment.
Sodir NM, Pathria G, Adamkewicz JI, Kelley EH, et al · · 2023 · cited 69× · PMID 37682219 · DOI 10.1158/2159-8290.cd-23-0383 -
Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4 -
KRAS Mutations in Solid Tumors: Characteristics, Current Therapeutic Strategy, and Potential Treatment Exploration.
Yang Y, Zhang H, Huang S, Chu Q. · · 2023 · cited 50× · PMID 36675641 · DOI 10.3390/jcm12020709 -
Next-generation therapies for pancreatic cancer.
Buckley CW, O'Reilly EM. · · 2024 · cited 33× · PMID 38415709 · DOI 10.1080/17474124.2024.2322648 -
Targeted therapy for pancreatic ductal adenocarcinoma: Mechanisms and clinical study.
Kung HC, Yu J. · · 2023 · cited 28× · PMID 36814688 · DOI 10.1002/mco2.216 -
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 -
From bench to bedside: current development and emerging trend of KRAS-targeted therapy.
Chen Y, Liu QP, Xie H, Ding J. · · 2024 · cited 23× · PMID 38049578 · DOI 10.1038/s41401-023-01194-4
Verify or expand the search:
- PubMed search for NCT05163028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
- NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
Other HUYABIO International, LLC. trials
Trials by the same sponsor.
- NCT05485974 — A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation · Phase 1 · active not recruiting
- NCT05141357 — A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer · Phase 2 · terminated
- 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 NCT05163028 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT05163028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing