Neratinib HER Mutation Basket Study
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
- Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Provide written informed consent - Histologically confirmed cancers for which no curative therapy exists - Documented HER2 or EGFR exon 18 mutation - Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol - At least one measurable lesion, defined by RECIST v1.1
- Participants harboring ineligible somatic HER2 mutations - Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib, tucatinib, poziotinib) - Participants who are receiving any other anticancer agents - Symptomatic or unstable brain metastases - Women who are pregnant or breast-feeding There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, solid tumors (NOS) and lung cancers containing EGFR exon 18 mutations. Cohorts closed to enrollment in Amendment 6: gastroesophageal, biliary, ovarian, solid tumor (NOS) HER4 mutant, and fibrolamellar carcinoma.||
Neratinib and Paclitaxel
|Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.||
Neratinib and Trastuzumab
|Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers. Cohorts closed to enrollment in Amendment 6: colorectal, lung cancer HER2 mutant.||
Neratinib, Fulvestrant and Trastuzumab (Randomized)
|Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.||
Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)
|Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with CDK4/6i naïve) breast cancers.||
- Puma Biotechnology, Inc.
Study ContactPuma Biotechnology, Inc. Clinical Operations Senior Director
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology (for example HER2 mutant cervical cancer). The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each participant after their last dose of neratinib or until initiation of additional anti-cancer therapy.