Clinical trials: HER2 Mutation
Advanced Solid Tumor, Non Small Cell Lung Cancer
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations
- Trial name
- NCT05532696
- Testing
- ABT-101
- Where
- 5 sites in Taiwan
- Volunteers
- 61 people
- Sponsor
- Anbogen Therapeutics, Inc.
Breast Cancer, Triple Negative Breast Neoplasms
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency.
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, HRpos Breast Neoplasms, BRCA 1 /2 and / or HRD
- Trial name
- GeparOla (NCT02789332)
- Testing
- PwO, PwCb, EC
- Where
- 12 sites in Germany
- Volunteers
- 107 people
- Sponsor
- GBG Forschungs GmbH
HER2-positive Breast Cancer
PIK3CA in HER2+ BC and pCR Trial
The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS.
- Trial name
- NCT05750693
- Testing
- PIK3CA analysis
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, RC48, Disitamab Vedotin
- Trial name
- NCT05847764
- Testing
- RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L, RC48+Furmonertinib, 2L+
- Where
- China
- Volunteers
- 95 people
- Sponsor
- Sun Yat-sen University
Lung Cancer
Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression
The goal of this clinical trial is to learn ifDisitamab Vedotin in combination with tislelizumab and bevacizumab can treat in locally advanced or metastatic non-small cell lung cancer patients with HER2…
- Trial name
- NCT06749860
- Testing
- Disitamab Vedotin + tislelizumab + bevacizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
BRCA-Mutated Breast Carcinoma, HER2-negative Breast Cancer
Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab
This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy.
- Trial name
- NCT06516289
- Testing
- HRS-1167, Famitinib, Camrelizumab
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Fudan University
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
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.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
Breast Cancer
A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer
This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers.
- Trial name
- NCT05203445
- Testing
- Olaparib, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non-small Cell Lung Cancer
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer…
- Trial name
- NCT07195695
- Testing
- Zongertinib, Pembrolizumab, Atezolizumab
- Where
- 202 sites in United States, Argentina and 26 more
- Volunteers
- 400 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer Stage IV
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was…
- Trial name
- SAFIR 03 (NCT05625087)
- Testing
- Alpelisib, Ribociclib
- Where
- 44 sites in France
- Volunteers
- 4 people
- Sponsor
- UNICANCER
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor…
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06378658
- Testing
- BAY2927088, Esomeprazole, Food
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Bayer
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants
Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body.
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06221475
- Testing
- BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion, [14C]-BAY2927088 oral solution
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bayer
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication, Disitamab Vedotin
- Trial name
- NCT06185400
- Testing
- Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib), pyrotinib
- Volunteers
- 108 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
This is an open-label, randomized, multi-center phase II study to evaluate the safety, tolerability, PK, and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors.
- Trial name
- NCT06516926
- Testing
- SHR-4602
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Adult Solid Neoplasm, Bladder Carcinoma
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that…
- Conditions
- Adult Solid Neoplasm, Bladder Carcinoma, Colon Carcinoma, Estrogen Receptor Negative
- Trial name
- NCT02432963
- Testing
- Laboratory Biomarker Analysis, Modified Vaccinia Virus Ankara Vaccine Expressing p53, Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
Esophageal Cancer, Gastric Adenocarcinoma
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.
- Conditions
- Esophageal Cancer, Gastric Adenocarcinoma, HER2 Gene Mutation
- Trial name
- NCT06123338
- Testing
- Pembrolizumab, Trastuzumab, Oxaliplatin
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Memorial Sloan Kettering Cancer Center