Clinical trials: HER2-positive Solid Tumor
HER2-positive Solid Tumors, HER2-positive Breast Cancer
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
- Conditions
- HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Gastroesophageal Cancer
- Trial name
- NCT04278144
- Testing
- BDC-1001, Nivolumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 175 people
- Sponsor
- Bolt Biotherapeutics, Inc.
Esophageal Neoplasms, Gastric Neoplasms Malignant
[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors
The goal of this phase II clinical trial is to improve the selection of patients with solid tumors who would benefit from effective treatment with HER2 targeted drugs.
- Conditions
- Esophageal Neoplasms, Gastric Neoplasms Malignant, Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT05619016
- Testing
- [68Ga]Ga-ABY-025 PET, Biopsy and analysis of HER2 expression
- Where
- Sweden
- Volunteers
- 72 people
- Sponsor
- Karolinska University Hospital
HER2-positive, Locally Advanced Solid Tumor
SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive…
- Conditions
- HER2-positive, Locally Advanced Solid Tumor, Immunotherapy, Sintilimab
- Trial name
- NCT05218148
- Testing
- sintilimab, Trastuzumab, S-1 plus oxaliplatin
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Aiping Zhou
Solid Tumors
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
- Trial name
- NCT02881138
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
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.
Neoplasms
First-in-human Study to Investigate Safety, Blood Levels and Activity of MP0274 in Cancer Patients With HER2-positive Solid Tumors
This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for the treatment of HER2-positive cancers.
- Trial name
- NCT03084926
- Testing
- MP0274
- Where
- 4 sites in Germany, Switzerland and 1 more
- Volunteers
- 22 people
- Sponsor
- Molecular Partners AG
Advanced Solid Tumor
Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors
This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.
- Trial name
- NCT04934514
- Testing
- IAH0968, Gemcitabine, Cisplatin
- Where
- China
- Volunteers
- 97 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC…
- Conditions
- Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC, Estrogen-receptor-positive Breast Cancer
- Trial name
- NCT04504916
- Testing
- Zilovertamab vedotin
- Where
- 14 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Advanced Solid Tumor
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT04941339
- Testing
- MRG002
- Where
- China
- Volunteers
- 74 people
- Sponsor
- Shanghai Miracogen Inc.
HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Trial name
- NCT04450732
- Testing
- GQ1001
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 96 people
- Sponsor
- GeneQuantum Healthcare (Suzhou) 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
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
- Trial name
- CONTRAST (NCT05555251)
- Testing
- BI-1607, Trastuzumab
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- BioInvent International AB
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, 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
Stomach Neoplasms, Solid Tumor
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects…
- Trial name
- NCT06504732
- Testing
- IAH0968, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 574 people
- Sponsor
- SUNHO（China）BioPharmaceutical 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
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.
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.