Protocol Title: A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

Sponsor: Huya Bio

Protocol Number: HBI-2438-101

Key Criteria

§  Patient has histologically or cytologically confirmed advanced solid tumors harboring KRAS G12C mutations.  
§  Disease has progressed after treatment with standard of care and with no available therapy of proven efficacy
§  Minimum of 1 measurable lesion per RECIST v1.1
§  Patient is able to provide archival (within 1 year) or new (within 42 days) tumor tissue
§  Patient can swallow oral medications and does not have GI abnormalities affecting drug absorption
§  Excluded if
·         History of another concurrent malignancy within three years before entering study (unless malignancy was treated with curative intent and is unlikely to relapse)
·         Patient has untreated or symptomatic CNS metastases
·         Patient was treated with any KRAS G12C inhibitor

Talking Points

  • Study drug is a KRAS G12C mutation inhibitor and is orally administered
    • This study drug is being developed for treating solid tumors with KRAS G12C mutation like non-small cell lung cancer, pancreatic adenocarcinoma, colorectal cancer
    • Maximum treatment duration is 1 year but can be extended beyond if treatment continues to be clinically beneficial
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