Clinical trials: HER2-positive Solid Cancers
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
HER2 Positive Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer
TAC T-cells for the Treatment of HER2-positive Solid Tumors
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).
- Trial name
- TACTIC-2 (NCT04727151)
- Testing
- TAC01-HER2, TAC01-HER2 plus pembrolizumab
- Where
- 11 sites in United States, Canada
- Volunteers
- 28 people
- Sponsor
- Triumvira Immunologics, Inc.
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
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Solid Tumor
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With Solid Tumor
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor
- Trial name
- NCT04151329
- Testing
- BAT1306 and BAT8001 2.4mg/kg, BAT1306 and BAT8001 3.6mg/kg
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Bio-Thera Solutions
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
Solid Tumor, Breast Cancer
Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.
The study comprises two phases: Phase 1a and Phase 1b. The purpose of the study is to observe the safety， tolerability and efficacy of FS-1502.
- Trial name
- NCT03944499
- Testing
- FS-1502
- Where
- 12 sites in China
- Volunteers
- 161 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
HER-2 Positive Advanced Solid Tumors
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary…
- Trial name
- NCT05957536
- Testing
- D3L-001
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
HER2-positive Advanced Solid Tumors
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
- Trial name
- NCT05245058
- Testing
- SPH5030 tablets
- Where
- 17 sites in China
- Volunteers
- 150 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
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.
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Currently, tyrosine kinase inhibitor (TKI) remains the standard of care for oncogene-driven non-small cell lung cancer (NSCLC). However, almost all oncogene-driven NSCLCs would develop acquired resistance against TKI in clinical…
- Conditions
- Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation, ALK Fusion-positive Solid or CNS Tumors, ROS1 Fusion Positive
- Trial name
- NCT07122882
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Chang Gung Memorial Hospital
Non-Small Cell Lung Cancer, Breast Cancer
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, Breast Cancer, Pancreatic Cancer
- Trial name
- NCT02403271
- Testing
- Ibrutinib, Durvalumab
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Pharmacyclics LLC.
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of 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
HER2-Positive Solid Tumor
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.
- Trial name
- NCT05523947
- Testing
- YH32367
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 147 people
- Sponsor
- Yuhan Corporation
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.
Esophageal Cancer, Gastric Cancer
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in…
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT06500052
- Testing
- BL-M17D1
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
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
Breast Cancer, Gastric Cancer
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic…
- Conditions
- Breast Cancer, Gastric Cancer, Solid Tumors, NSCLC
- Trial name
- NCT02500199
- Testing
- Pyrotinib
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- Hengrui Therapeutics, Inc.