Clinical trials: Her2/Neu Positive Advanced Solid Tumors
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
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
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Breast Cancer, Hematologic Neoplasms
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose.
- Trial name
- NCT00526045
- Testing
- AUY922 2 mg/m2
- Where
- 10 sites in United States, Netherlands and 2 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in HER2-Positive Solid Tumors
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03330561
- Testing
- PRS-343
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
Advanced Solid Tumors, Advanced or Metastatic Gastric Cancer
A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG002 in patients with HER2-positive…
- Conditions
- Advanced Solid Tumors, Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Cancer
- Trial name
- NCT04492488
- Testing
- MRG002
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- Shanghai Miracogen Inc.
Breast Cancer
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of…
- Trial name
- NCT00741260
- Testing
- Neratinib, Capecitabine
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 105 people
- Sponsor
- Puma Biotechnology, Inc.
Colorectal Cancer Metastatic, Adenocarcinoma of Colon
Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic…
- Trial name
- NCT07462650
- Testing
- EB-DUO-CAR-NK-CEA/GCC (IV)
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Biotech
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.
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.
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
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
HER2-positive Solid Tumors
Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors
This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.
- Trial name
- NCT04521179
- Testing
- KN026 combination
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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.
Breast Cancer (Advanced/Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ 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 (Advanced/Metastatic), HER2-positive Breast Cancer, Triple-negative Breast Cancer
- Trial name
- NCT07510802
- Testing
- Dual-target CAR-NK cells, Lymphodepleting, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Solid Tumor, HER-2 Protein Overexpression
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting…
- Trial name
- NCT03680560
- Testing
- ACTR T Cell Product, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cogent Biosciences, Inc.
Her2-positive/Low-expression Urinary and Digestive Tract Tumors
A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors
Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors.
- Trial name
- NCT06031584
- Testing
- BL-M07D1
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
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