Clinical trials: Her2/Neu Positive Advanced Solid Tumors, open to volunteers
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.
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
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
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
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
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
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 Advanced Malignant Solid Tumors
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
- Trial name
- NCT06658951
- Testing
- Anti-HER2 CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- UTC Therapeutics Inc.
Breast Cancer, Locally Advanced or Metastatic Solid Tumor
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors
In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting…
- Trial name
- NCT05461768
- Testing
- BL-M07D1
- Where
- 7 sites in China
- Volunteers
- 348 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
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
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
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.
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.