HER2 Mutation: Clinical Trials

2 recruiting, 1 not yet recruiting. 3 Phase 2, 1 Phase 1.

By phase and status

Phase	Trials	Status
Phase 2	3	Recruiting 2, Not yet recruiting 1
Phase 1	1	Recruiting 1

Follow HER2 Mutation: new trials by email Literature Review of HER2 Mutation trials Research Report on HER2 Mutation

Trials (filtered) newest first · largest first

All 3 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. Zongertinib (BI 1810631), Fulvestrant - Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer	Phase 2	Not yet recruiting	MedSIR	25	2026-10-04	2026-06-01
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) BAY2927088 - Advanced Solid Tumors, HER2 Mutation	Phase 2	Recruiting	Bayer	111	2025-02-13	2026-11-04
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) BAY2927088_formulation A, BAY2927088_formulation B_1, BAY2927088_formulation B_2 - Advanced Non-small Cell Lung Cancer, EGFR Mutation	Phase 1 / Phase 2	Recruiting	Bayer	430	2021-10-25	2026-11-12

Narrower conditions

Biliary Tract Neoplasms (1)  ·  Breast Neoplasms (1)  ·  Colorectal Neoplasms (1)  ·  Endometrial Neoplasms (1)  ·  Esophageal Neoplasms (1)  ·  Gallbladder Neoplasms (1)  ·  Gastrointestinal Neoplasms (1)  ·  Gastrointestinal Stromal Tumors (1)  ·  Ovarian Neoplasms (1)  ·  Pancreatic Neoplasms (1)  ·  Sarcoma (1)  ·  Stomach Neoplasms (1)  ·  Urinary Bladder Neoplasms (1)  ·  Uterine Cervical Neoplasms (1)

Broader conditions

Adnexal Diseases (1)  ·  Biliary Tract Diseases (1)  ·  Breast Diseases (1)  ·  Colonic Diseases (1)  ·  Digestive System Diseases (1)  ·  Digestive System Neoplasms (1)  ·  Endocrine Gland Neoplasms (1)  ·  Endocrine System Diseases (1)  ·  Esophageal Diseases (1)  ·  Female Urogenital Diseases (1)  ·  Female Urogenital Diseases and Pregnancy Complications (1)  ·  Gallbladder Diseases (1)  ·  Gastrointestinal Diseases (1)  ·  Genital Diseases (1)  ·  Genital Diseases, Female (1)

Interventions

Fulvestrant (1)

Sponsors

Bayer (2)  ·  MedSIR (1)

Countries

China (2)  ·  France (2)  ·  Italy (2)  ·  Japan (2)  ·  South Korea (2)  ·  Spain (2)  ·  United States (2)  ·  Australia (1)  ·  Belgium (1)  ·  Brazil (1)  ·  Canada (1)  ·  Denmark (1)  ·  Hong Kong (1)  ·  Israel (1)  ·  Netherlands (1)

Results publications

PMID 41104928

NIH funding

2023 (1)