Clinical trials: HER2-positive Solid Tumor
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
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
Breast Neoplasms
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in…
- Trial name
- NCT03284723
- Testing
- PF-06804103, PF-06804103 + Palbociclib +Letrozole
- Where
- 46 sites in United States, Australia and 4 more
- Volunteers
- 95 people
- Sponsor
- Pfizer
HER2-positive Solid Tumors
A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are…
- Trial name
- NCT06806982
- Testing
- VRN101099
- Where
- Australia
- Volunteers
- 72 people
- Sponsor
- Voronoi, Inc
Breast Cancer, Locally Advanced or Metastatic Solid Tumor
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors
In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting…
- Trial name
- NCT05461768
- Testing
- BL-M07D1
- Where
- 7 sites in China
- Volunteers
- 348 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
- Trial name
- CONTRAST (NCT05555251)
- Testing
- BI-1607, Trastuzumab
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- BioInvent International AB
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive…
- Trial name
- SUMMIT (NCT01953926)
- Testing
- Neratinib, Fulvestrant, Trastuzumab
- Where
- 60 sites in United States, Australia and 11 more
- Volunteers
- 582 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory
Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors
RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.
- Conditions
- Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory, HER-2 Antibody Inhibitor Therapy Refactory
- Trial name
- CART-HER-2 (NCT01935843)
- Testing
- CART-HER-2
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chinese PLA General Hospital
Her2/Neu Positive Advanced Solid Tumors
Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors
Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose.
- Trial name
- NCT01569412
- Testing
- Ertumaxomab
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- Krankenhaus Nordwest
HER2-positive Solid Tumors, HER2-positive Breast Cancer
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
- Conditions
- HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Gastroesophageal Cancer
- Trial name
- NCT04278144
- Testing
- BDC-1001, Nivolumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 175 people
- Sponsor
- Bolt Biotherapeutics, Inc.
HER2-Positive Advanced Biliary Tract Cancer
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for…
- Trial name
- NCT04578444
- Testing
- Zanidatamab
- Where
- 17 sites in United States, France and 3 more
- Sponsor
- Jazz Pharmaceuticals
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
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
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.
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
Solid Tumors, Breast Cancer
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not…
- Trial name
- NCT00773344
- Testing
- Tanespimycin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics