Clinical trials: HER2-positive Solid Cancers
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 18 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
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
Solid Tumor, Advanced Breast Cancer
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
The hypothesis is that abemaciclib synergizes with autophagy inhibitor hydroxychloroquine (HCQ/ Plaquenil), inducing apoptosis leading to tumor regression.
- Trial name
- NCT04316169
- Testing
- Abemaciclib, Hydroxychloroquine 200 mg, Faslodex
- Where
- United States
- Sponsor
- Medical College of Wisconsin
NRG1 Fusion, Pancreatic Cancer
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128…
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult
- Trial name
- NCT04100694
- Testing
- MCLA-128
- Sponsor
- Merus B.V.
Adenocarcinoma (NOS), Anal Cancer
DESTINY-PANTUMOUR04
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease…
- Conditions
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- DP-04 (NCT07124000)
- Testing
- Trastuzumab deruxtecan
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Breast Cancer, Ovarian Cancer
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in…
- Conditions
- Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT05905341
- Testing
- PF-07224826, Fulvestrant
- Sponsor
- Pfizer
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
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, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics
HER2-positive Advanced Solid Tumors
A Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
This is a study of DP303c in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT05810103
- Testing
- DP303c
- Where
- China
- Volunteers
- 12 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
HER-2 Protein Overexpression, HER-2 Gene Amplification
Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer.
- Trial name
- BIOs-Her (NCT04215159)
- Testing
- Trastuzumab biosimilar, Gemcitabine Hydrochloride, Irinotecan Hydrochloride
- Volunteers
- 42 people
- Sponsor
- Jin-Hee Ahn
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.
Bladder Cancer, Head and Neck Squamous Cell Carcinoma
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer.
- Conditions
- Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland, Lung Cancer
- Trial name
- VISTA (NCT03740256)
- Testing
- CAdVEC
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Baylor College of Medicine
Solid Tumor, Breast Cancer
Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy
To determine the Maximally Tolerable Dose (MTD) of KOS-1022 when administered weekly in combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients with advanced solid tumor malignancies
- Trial name
- NCT00803556
- Testing
- Alvespimycin, Trastuzumab, Paclitaxel
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Bristol-Myers Squibb
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
Advanced Solid Tumor, Metastatic Breast Cancer
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination…
- Trial name
- NCT04872166
- Testing
- BTX-A51
- Where
- 6 sites in United States
- Volunteers
- 112 people
- Sponsor
- Edgewood Oncology Inc.
HER2 Gene Mutation, Advanced Solid Tumors
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
- Trial name
- RAD202 (NCT06824155)
- Testing
- 177Lu-RAD202
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
Solid Cancers
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with…
- Trial name
- NCT00927589
- Testing
- carboplatin, docetaxel, trastuzumab
- Where
- 20 sites in United States
- Volunteers
- 59 people
- Sponsor
- Genentech, Inc.
Radiomic, Radiomics
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic…
- Conditions
- Radiomic, Radiomics, Breast Cancer Metastatic, Breast Cancer Stage IV
- Trial name
- RADIOSPHER2 (NCT07030569)
- Testing
- Trastuzumab deruxtecan (DS-8201a)
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano