Clinical trials: HER-2 Protein Overexpression
Solid Tumor
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
- Trial name
- NCT03804515
- Testing
- 14C-labeled poziotinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Neoplasm, Gastrointestinal
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed…
- Trial name
- NCT03329690
- Testing
- DS-8201a, Physician's Choice
- Where
- 66 sites in Japan, South Korea
- Volunteers
- 233 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Neoplasms, Breast
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified…
- Trial name
- NCT00281658
- Testing
- Lapatinib (GW572016) oral tablets, Paclitaxel infusion
- Where
- 54 sites in Brazil, China and 6 more
- Volunteers
- 444 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab…
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2 Positive Solid Tumors, HER2 Amplification
- Trial name
- NCT06328738
- Testing
- ELVN-002, Trastuzumab, 5-Fluorouracil
- Where
- 31 sites in United States, Belgium and 5 more
- Volunteers
- 275 people
- Sponsor
- Enliven Therapeutics
Melanoma, Stage II, HER2-positive
A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
- Conditions
- Melanoma, Stage II, HER2-positive, Advanced Melanoma
- Trial name
- NCT05135715
- Testing
- RC48-ADC
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms, Gastric Neoplasm
A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other…
- Conditions
- Breast Neoplasms, Gastric Neoplasm, Solid Tumors
- Trial name
- NCT03255070
- Testing
- ARX788
- Where
- 12 sites in United States, Australia
- Volunteers
- 106 people
- Sponsor
- Ambrx, Inc.
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer.
- Trial name
- DL03 (NCT04686305)
- Testing
- T-DXd, Durvalumab, Cisplatin
- Where
- 91 sites in United States, Australia and 17 more
- Volunteers
- 304 people
- Sponsor
- AstraZeneca
Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728.
- Trial name
- NCT03410927
- Testing
- TAS0728
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Taiho Oncology, Inc.
Urothelial Carcinoma
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.
- Trial name
- NCT04879329
- Testing
- disitamab vedotin, pembrolizumab
- Where
- 221 sites in United States, Argentina and 10 more
- Volunteers
- 372 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Solid Tumors
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in…
- Trial name
- NCT05315700
- Testing
- ORIC-114, Chemotherapy drug
- Where
- 42 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- ORIC Pharmaceuticals
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally…
- Trial name
- NCT02015676
- Testing
- trastuzumab, paclitaxel, Myocet
- Where
- Spain
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Breast Cancer, Gastric Cancer
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry…
- Conditions
- Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer
- Trial name
- NCT06695845
- Testing
- Zanidatamab
- Where
- 28 sites in United States, South Korea and 1 more
- Volunteers
- 200 people
- Sponsor
- Jazz Pharmaceuticals
Solid Tumor, HER-2 Protein Overexpression
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting…
- Trial name
- NCT03680560
- Testing
- ACTR T Cell Product, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cogent Biosciences, Inc.
Urothelial Carcinoma
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer.
- Trial name
- NCT05902494
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 389 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
Biliary Tract Cancer
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice…
- Trial name
- NCT06282575
- Testing
- Zanidatamab, Cisplatin, Gemcitabine
- Where
- 185 sites in United States, Argentina and 23 more
- Volunteers
- 286 people
- Sponsor
- Jazz Pharmaceuticals
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression…
- Trial name
- NCT04714190
- Testing
- RC48-ADC, Paclitaxel injection, Irinotecan Hydrochloride Injection
- Where
- 52 sites in China
- Volunteers
- 351 people
- Sponsor
- RemeGen Co., Ltd.
HER-2 Gene Amplification, HER2-positive Gastric Cancer
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with…
- Conditions
- HER-2 Gene Amplification, HER2-positive Gastric Cancer, HER2-positive Breast Cancer, HER-2 Protein Overexpression
- Trial name
- NCT04650451
- Testing
- chimeric antigen receptor (CAR) T cell therapy
- Where
- 7 sites in United States
- Volunteers
- 220 people
- Sponsor
- Bellicum Pharmaceuticals
Urothelial Carcinoma
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra).
- Trial name
- NCT05911295
- Testing
- disitamab vedotin, pembrolizumab, gemcitabine
- Where
- 268 sites in United States, Argentina and 22 more
- Volunteers
- 412 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer