Clinical trials: Her2/Neu Positive Advanced Solid Tumors
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
HER2 Positive Gastric Cancer, Colorectal Cancer
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: Regimen A: FATE-NK100 as a monotherapy in subjects with advanced…
- Conditions
- HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, EGFR Positive Solid Tumor
- Trial name
- NCT03319459
- Testing
- FATE-NK100, Cetuximab, Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Fate Therapeutics
Carcinoma, Solid Tumor
ADC Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of HER-2 Positive Advanced Solid Tumors(PRaG3.0)
This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory…
- Trial name
- NCT05115500
- Testing
- ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
- Where
- 19 sites in China
- Volunteers
- 55 people
- Sponsor
- Second Affiliated Hospital of Soochow University
Solid Tumors
TrasGEX™: Phase 1 Study in Cancer Patients
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers.
- Trial name
- NCT01409343
- Testing
- TrasGEX™
- Where
- 5 sites in Austria, Germany and 2 more
- Volunteers
- 37 people
- Sponsor
- Glycotope GmbH
HER2-positive Advanced Solid Tumor
Study of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors
An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors
- Trial name
- NCT05423977
- Testing
- ZV0203
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Hangzhou Adcoris Biopharmacy Co., Ltd
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast Neoplasms
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: Xentuzumab in combination with abemaciclib Xentuzumab in combination with abemaciclib and hormonal therapies…
- Trial name
- NCT03099174
- Testing
- Xentuzumab, Abemaciclib, Letrozole
- Where
- 30 sites in United States, Denmark and 5 more
- Volunteers
- 133 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer, Gastric Cancer
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b.
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT06341647
- Testing
- AB-201, Cyclophosphamide, Fludarabine
- Sponsor
- GC Cell Corporation
Stomach Neoplasms, Solid Tumor
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects…
- Trial name
- NCT06504732
- Testing
- IAH0968, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 574 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the…
- Conditions
- Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma, Advanced Bladder Carcinoma, Advanced Breast Carcinoma
- Trial name
- NCT05969860
- Testing
- Clinical Encounter, Home Health Encounter, Quality-of-Life Assessment
- Where
- 2 sites in United States
- Volunteers
- 220 people
- Sponsor
- Mayo Clinic
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
HER2-Positive Solid Tumors
A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated…
- Trial name
- NCT04501770
- Testing
- Chort 1 of M802, Chort 2 of M802, Cohort 3 of M802
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Wuhan YZY Biopharma Co., Ltd.
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors.
- Trial name
- HF50 (NCT06822998)
- Testing
- HF50
- Where
- China
- Volunteers
- 10 people
- Sponsor
- HighField Biopharmaceuticals Corporation
Neoplasms
First-in-human Study to Investigate Safety, Blood Levels and Activity of MP0274 in Cancer Patients With HER2-positive Solid Tumors
This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for the treatment of HER2-positive cancers.
- Trial name
- NCT03084926
- Testing
- MP0274
- Where
- 4 sites in Germany, Switzerland and 1 more
- Volunteers
- 22 people
- Sponsor
- Molecular Partners AG
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 66 sites in United States, China and 1 more
- Volunteers
- 952 people
- Sponsor
- Genmab
HER2-positive Breast Cancer, Male Breast Cancer
Akt Inhibitor MK2206 in Combination With Lapatinib Ditosylate in Patients With Advanced or Metastatic Solid Tumors or Breast Cancer
This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread to other places in the body.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer
- Trial name
- NCT01245205
- Testing
- Akt inhibitor MK2206, lapatinib ditosylate, pharmacological study
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
Solid Tumors
Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors
A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.
- Trial name
- NCT02881190
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 57 people
- Sponsor
- RemeGen Co., Ltd.
Neoplasms, Solid Tumors
An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2…
- Conditions
- Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm
- Trial name
- NCT07631871
- Testing
- Zanidatamab
- Volunteers
- 10 people
- Sponsor
- Haihua Yuan