TAS2940 / Otsuka - LARVOL DELTA

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer (clinicaltrials.gov) - P1 | N=29 | Terminated | Sponsor: Taiho Oncology, Inc. | Completed ➔ Terminated; After careful review of Taiho's ongoing portfolio and data obtained so far in the context of broader landscape of clinical development in NSCLC HER2mut, Sponsor has made a strategic decision to terminate this study and not based on safety concerns.

Trial termination • Brain Cancer • Breast Cancer • Glioblastoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Taiho Oncology, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: May 2025 ➔ Jan 2025

Trial completion • Trial primary completion date • Brain Cancer • Breast Cancer • Glioblastoma • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer (clinicaltrials.gov) - P1 | N=29 | Active, not recruiting | Sponsor: Taiho Oncology, Inc. | Recruiting ➔ Active, not recruiting | N=42 ➔ 29

Enrollment change • Enrollment closed • Metastases • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A phase 1, open-label, first-in-human study of TAS2940 in patients with advanced solid tumors. (ASCO 2023) - P1 | "Recruitment is ongoing. Clinical trial information: NCT04982926."

Clinical • Metastases • P1 data • Brain Cancer • Breast Cancer • CNS Tumor • Gastric Cancer • Gastrointestinal Cancer • Glioblastoma • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TAS2940 inhibits intracranial tumor growth and prolongs survival in HER2-aberrant and EGFR-amplified patient-derived xenograft models (AACR 2023) - P1 | "HER2-targeted tyrosine kinase inhibitors lapatinib, neratinib, and tucatinib and the HER2-targeted antibodies trastuzumab and pertuzumab, in combination with chemotherapy, have been shown to improve survival of patients with HER2 overexpressing BC in the presence of brain metastases...TAS2940 is an irreversible pan-ErbB inhibitor with greater brain-penetrability than poziotinib, tucatinib, and neratinib. Here, we demonstrate that TAS2940 induces downregulation of phosphorylated HER2/EGFR, reduces tumor burden, and promotes a significant increase in survival in intracranial xenograft mouse models with HER2-amplification (BC), HER2-Exon20 insertion mutation (NSCLC), and EGFR-amplification (GBM). These promising preclinical data highlight potential novel therapeutic strategies for patients with EGFR-aberrant GBM and brain metastases harboring HER2/EGFR alterations, and may help support the advancement of the ongoing first-in-human clinical trial (NCT04982926) for..."

Preclinical • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

TAS2940, a novel brain-penetrable pan-ERBB inhibitor, exhibits tumor regression and prolongs survival in intracranial models bearing ERBB aberrations (AACR 2023) - "Several pan-ERBB inhibitors are clinically available or under clinical development, such as afatinib, neratinib, and poziotinib. TAS2940 is a novel potent and selective pan-ERBB inhibitor with high brain penetrability in vivo. These results support the clinical development of TAS2940 in primary and metastatic brain tumors driven by ERBB genetic aberrations."

Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

TAS2940, a Novel Brain-Penetrable Pan-ERBB Inhibitor, for Tumors with HER2 and EGFR Aberrations. (PubMed, Cancer Sci) - "TAS2940 has promising therapeutic effects in preclinical study against cancers harboring HER2/EGFR mutations, especially metastatic and primary brain tumors. Our results highlight potential novel strategies against lung cancers with brain metastases harboring HER2/EGFR ex20 insertions and glioblastomas with EGFR aberrations."

Journal • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Immunology • Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Taiho Oncology, Inc.; Not yet recruiting ➔ Recruiting; N=142 ➔ 42

Clinical • Enrollment change • Enrollment open • Brain Cancer • Breast Cancer • Glioblastoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer (clinicaltrials.gov) - P1; N=142; Not yet recruiting; Sponsor: Taiho Oncology, Inc.

New P1 trial • Brain Cancer • Breast Cancer • Glioblastoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2