Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Albumin-Bound Paclitaxel; Estradiol; Fulvestrant; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants harboring ineligible somatic HER2 mutations

• Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible

• 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.