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10 clinical studies listed.

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HER2 Gene Mutation

Tundra lists 10 HER2 Gene Mutation clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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ACTIVE NOT RECRUITING

NCT06178445

Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients. Patients suffering from previously untreated HER2 (human epidermal growth factor receptor 2) positive, unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab, trastuzumab and gemcitabine/cisplatin (GemCis).

Gender: All

Ages: 18 Years - Any

Updated: 2026-03-27

Biliary Tract Cancer
HER2 Gene Mutation
HER2
NOT YET RECRUITING

NCT07436858

Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer

The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-27

1 state

Lung Cancer (NSCLC)
HER2 Expression
HER2 Gene Mutation
RECRUITING

NCT04620187

Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-24

5 states

Salivary Gland Cancer
HER2 Gene Mutation
RECRUITING

NCT06824155

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 consisting of an Imaging Period with 177Lu-RAD202im(imaging dose) and a Treatment Period with 177Lu-RAD202tr(treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-11

3 states

HER2 Gene Mutation
Advanced Solid Tumors
RECRUITING

NCT06123338

A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer

The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.

Gender: All

Ages: 18 Years - Any

Updated: 2026-01-29

5 states

Esophageal Cancer
Gastric Adenocarcinoma
HER2 Gene Mutation
ACTIVE NOT RECRUITING

NCT06714617

Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors

The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.

Gender: All

Ages: 18 Years - Any

Updated: 2025-11-04

7 states

Breast Cancer Stage III
HER2-positive Metastatic Breast Cancer
Unresectable Breast Carcinoma
+11
RECRUITING

NCT05274048

Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.

Gender: All

Ages: 18 Years - Any

Updated: 2025-10-29

3 states

Gastric Cancer
Gastrointestinal Cancer
HER2 Gene Mutation
RECRUITING

NCT06449989

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer

GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.

Gender: All

Ages: 18 Years - Any

Updated: 2025-08-12

1 state

Colorectal Cancer Metastatic
Brain Metastases, Adult
Ras (KRAS or NRAS) Gene Mutation
+3
ACTIVE NOT RECRUITING

NCT05650879

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

Gender: All

Ages: 18 Years - Any

Updated: 2025-07-15

17 states

HER2 Mutant Non-small Cell Lung Cancer
HER2-positive Metastatic Breast Cancer
HER2 Gene Mutation
+1
RECRUITING

NCT06383533

Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma

It is a single arm, open-label, phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma

Gender: All

Ages: 18 Years - Any

Updated: 2024-04-26

1 state

Bile Duct Adenocarcinoma Non-Resectable
HER2 Gene Mutation