Clinical trials: HER2-positive Solid Cancers
Advanced Solid Tumor
Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors
This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.
- Trial name
- NCT04934514
- Testing
- IAH0968, Gemcitabine, Cisplatin
- Where
- China
- Volunteers
- 97 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Advanced Solid Tumors, Metastatic Colon Cancer
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
- Conditions
- Advanced Solid Tumors, Metastatic Colon Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT03251378
- Testing
- Fruquintinib (HMPL-013)
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- Hutchison Medipharma Limited
Male Breast Cancer, Recurrent Breast Cancer
Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have solid tumors.
- Conditions
- Male Breast Cancer, Recurrent Breast Cancer, Recurrent Endometrial Carcinoma, Recurrent Gastric Cancer
- Trial name
- NCT00028535
- Testing
- trastuzumab, paclitaxel, recombinant interleukin-12
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Cancer Institute (NCI)
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
Breast Cancer, Breast Neoplasms
Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Tumors, Cancer
- Trial name
- NCT00807859
- Testing
- AMG 386 30 mg/kg, Paclitaxel and Trastuzumab, AMG 386 30 mg/kg, Capecitabine and Lapatinib, AMG 386 10 mgkg, Paclitaxel and Trastuzumab
- Where
- 23 sites in United States, Belgium and 1 more
- Volunteers
- 65 people
- Sponsor
- Amgen
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
Breast Cancer, Small Cell Lung Cancer
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity…
- Conditions
- Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT06257264
- Testing
- BG-68501, Fulvestrant, BGB-43395
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- BeiGene
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab…
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2 Positive Solid Tumors, HER2 Amplification
- Trial name
- NCT06328738
- Testing
- ELVN-002, Trastuzumab, 5-Fluorouracil
- Where
- 31 sites in United States, Belgium and 5 more
- Volunteers
- 275 people
- Sponsor
- Enliven Therapeutics
Breast Cancer, Metastatic
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive…
- Trial name
- ASPEN-09-03 (NCT07007559)
- Testing
- Evorpacept (ALX148), Trastuzumab, Paclitaxel
- Where
- 60 sites in United States, Canada and 6 more
- Volunteers
- 120 people
- Sponsor
- ALX Oncology Inc.
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from…
- Trial name
- NCT00095862
- Testing
- allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa, cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Wiseman Research Initiatives LLC
Advanced Solid Tumors, Lymphoma
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance.
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT03841110
- Testing
- FT500, Nivolumab, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Fate Therapeutics
Breast Cancer, Breast Cancer Stage IV
A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer
The purpose of this study to find out whether mirdametinib is a safe treatment for people with advanced solid tumor cancer that has certain mutations.
- Conditions
- Breast Cancer, Breast Cancer Stage IV, HER2-negative Breast Cancer, Solid Carcinoma
- Trial name
- NCT05054374
- Testing
- Mirdametinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
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
Her2 Amplified Solid Tumors, Metastatic Breast Cancer
A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
This study is an open-label Phase 1 trial of MM-111.
- Trial name
- Monotherapy (NCT00911898)
- Testing
- MM-111
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Merrimack Pharmaceuticals
HER2 Positive Solid Tumor
TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.
In recent years, there is increasing interest in antibodies for imaging, antibody-drug conjugates (ADC) and targeted radionuclide therapy (TRT).
- Trial name
- CleavHER (NCT07009184)
- Testing
- [111In]In-DOTA-TCO-trastuzumab, Small molecule tetrazine trigger component
- Where
- Netherlands
- Volunteers
- 19 people
- Sponsor
- Radboud University Medical Center
Advanced Solid Tumors
A Study of TAS-116 in Patients With Solid Tumors
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase.
- Trial name
- NCT02965885
- Testing
- TAS-116
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 31 people
- Sponsor
- Taiho Oncology, Inc.
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic…
- Conditions
- Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01217411
- Testing
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)