A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

  • Clinical Trial Information

    Trial Contact: Grofsik, Kiera; Donaldson, Karin M; Djuro, Victor; Frankos, Marie; Walton, Sherri

  • IRB No: T22.066.03

    Protocol Abbrev: TRIO HBI-2376-101

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: HBI-2376-101

    Treatment: HBI-2376 capsules SHP2 Inhibitor

    Therapies Involved: Chemotherapy ID: NCT05163028

  • Objective

    •   To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations

    •   To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations

    •   To initially evaluate the anti-tumor effects of HBI-2376 as assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    •   To evaluate changes in disease biomarkers

  • Key Eligibility

    To be eligible for participation in this study, subjects must meet all the following:

    1. At least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures.

    Type of Subject and Disease Characteristics
    2. Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology.
    3. Exhausted potential curative options (up to 2 prior lines of antineoplastic therapies which may include chemotherapy, targeted agents, radio-conjugates, immuno-conjugates, or check point inhibitors) and who are relapsed or refractory to, or intolerant of, or refuse approved, or standard of care established therapy known to provide clinical benefit for their condition.
    4. At least 1 measurable target lesion that meets the definition of RECIST v1.1. If there is no measurable lesion that has not undergone radiotherapy as the target lesion, can use a target lesion that received radiotherapy and imaging ≥4 weeks prior to the first dose of HBI-2376 and has confirmed progression of the lesion as the target lesion.
    5. Willing to provide newly obtained or archived tumor tissue samples either formalin-fixed paraffin embedded (FFPE) block, OR at least 14 to 16 unstained slides. Newly obtained tumor tissue is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Cycle 1 Day 1; subjects for whom newly obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen (within 1 year); FFPE tissue blocks are preferred to slides. Newly obtained core needle biopsies are preferred to archived tissue. Unused tumor tissue samples will be returned to the clinical site in a timely manner.