Clinical trials: HER2-positive Solid Tumor
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
Advanced Malignant Solid Tumors
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.
The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to…
- Trial name
- NCT05338957
- Testing
- MRG002+HX008
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Miracogen Inc.
Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Biomarker-positive EGFR/HER2- Expressing HNSCC
EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC
This example Phase 1/2 protocol evaluates allogeneic EGFR/HER2 dual-target CAR-NK cells in adults with recurrent or metastatic HNSCC whose tumors meet protocol-defined co-expression criteria for EGFR and HER2/ERBB2.
- Trial name
- DUAL-HN (NCT07617805)
- Testing
- EGFR/HER2 Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Beijing Biotech
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca
Solid Tumors, HER2-positive Breast Cancer
Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases
This trial will evaluate treatment for patients with solid tumors with active brain metastases. Patients will be treated with a theranostic or diagnostic agent.
- Trial name
- THERANOVA (NCT07178938)
- Testing
- Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)
- Volunteers
- 10 people
- Sponsor
- MedSIR
HER2-positive Advanced Solid Tumors
A Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
This is a study of DP303c in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT05810103
- Testing
- DP303c
- Where
- China
- Volunteers
- 12 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer, Advanced Solid Tumor
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2…
- Trial name
- NCT06299124
- Testing
- RGT-419B
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Regor Pharmaceuticals Inc.
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Solid Tumors, Breast Cancer
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not…
- Trial name
- NCT00773344
- Testing
- Tanespimycin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
NRG1 Fusion, Pancreatic Cancer
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128…
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult
- Trial name
- NCT04100694
- Testing
- MCLA-128
- Sponsor
- Merus B.V.
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
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.
Her2/Neu Positive Advanced Solid Tumors
Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors
Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose.
- Trial name
- NCT01569412
- Testing
- Ertumaxomab
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- Krankenhaus Nordwest
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
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.
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative
Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery
This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other places in the body and cannot be removed by…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative, GPNMB Positive, HER2/Neu Negative
- Trial name
- NCT03326258
- Testing
- Glembatumumab Vedotin, Ipilimumab, Laboratory Biomarker Analysis
- Sponsor
- National Cancer Institute (NCI)
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