Clinical trials: HER2-positive Solid Cancers, open to volunteers
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Metastatic Solid Tumor, Brain Metastases
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.
- Trial name
- NCT05673928
- Testing
- Trastuzumab emtansine, Tucatinib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc
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)
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.
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.
Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
- Trial name
- ELUCIDATE (NCT05985655)
- Testing
- GTAEXS617, SoC
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 230 people
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Advanced Solid Tumor
A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.
This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing…
- Trial name
- NCT05320874
- Testing
- KM257 Bispecific antibody
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Metastatic Breast Cancer, HER2-positive Breast Cancer
HER-2 B Cell Peptide Vaccine
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an…
- Conditions
- Metastatic Breast Cancer, HER2-positive Breast Cancer, EGFR Overexpression, Metastatic Esophageal Carcinoma
- Trial name
- NCT06414733
- Testing
- Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Pravin T.P Kaumaya
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
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
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
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 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
Neoplasms, Solid Tumors
An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2…
- Conditions
- Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm
- Trial name
- NCT07631871
- Testing
- Zanidatamab
- Volunteers
- 10 people
- Sponsor
- Haihua Yuan
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 67 sites in United States, China and 2 more
- Volunteers
- 952 people
- Sponsor
- Genmab
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
Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
Dual-Targeting CAR-NK Cells in 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…
- Conditions
- Colorectal Cancer, Metastatic Colorectal Adenocarcinoma, Unresectable Colorectal Cancer
- Trial name
- DUO-CRC-NK-111 (NCT07589517)
- Testing
- EB-DUO-CAR-NK-CEA/GCC, Lymphodepletion
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Biotech
HER2 Positive Advanced Solid Tumors
HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors
Chimeric antigen receptor modified T (CAR-T) cell therapy still has multiple difficulties in solid tumors, such as absence of tumor specific antigens, complex immunosuppressive tumor microenvironment, and tumor heterogeneity.
- Trial name
- NCT05681650
- Testing
- HypoSti.CAR-HER2 T cells, Albumin-bound paclitaxel, Cyclophosphamide
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chinese PLA General Hospital