Clinical trials: HER2-positive Non-Small Cell Lung Cancer
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Breast Cancer, Non-small Cell Lung Carcinoma
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
- Trial name
- NCT04042701
- Testing
- Trastuzumab deruxtecan (DS-8201a), Pembrolizumab
- Where
- 30 sites in United States, France and 2 more
- Volunteers
- 115 people
- Sponsor
- Daiichi Sankyo
HER2-positive Breast Cancer, Cervical Cancer
Tucatinib Continuation Study
The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment.
- Conditions
- HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms, Urothelial Cancer
- Trial name
- NCT07768358
- Testing
- tucatinib
- Volunteers
- 175 people
- Sponsor
- Pfizer
Breast Neoplasms, Lung Neoplasms
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive ([HR+]…
- Trial name
- NCT06974604
- Testing
- Dexamethasone oral
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brown University
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.
Sarcoma, Castrate Resistant Prostate Cancer
A Study of PRT2527 in Participants With Advanced Solid Tumors
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors.
- Conditions
- Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05159518
- Testing
- PRT2527
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prelude Therapeutics Incorporated
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Cutaneous Melanoma, Locally Advanced Mucosal Melanoma
- Trial name
- NCT05098210
- Testing
- Neoantigen Peptide Vaccine, Nivolumab, Poly ICLC
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Fred Hutchinson Cancer Center
Carcinoma, Non-Small-Cell Lung
T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC
This is a single arm open-label multi-center phase II study, investigating disease control rate after 3 months of treatment with trastuzumab-emtansine/osimertinib combination therapy in patients with advanced EGFR mutation…
- Trial name
- TRAEMOS (NCT03784599)
- Testing
- Trastuzumab emtansine, Osimertinib
- Where
- 5 sites in Netherlands
- Volunteers
- 28 people
- Sponsor
- The Netherlands Cancer Institute
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 OR TROP2 Positive Non-Small Cell Lung Cancer
Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids
A case-control study was conducted to evaluate the efficacy and mechanism of action of antibody-drug conjugates (ADCs) in lung cancer, utilizing patient-derived organoid (PDO)-immune co-cultures.
- Trial name
- NCT07610616
- Testing
- Antibody-drug conjugate (ADC) combination therapy
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Guangzhou Institute of Respiratory Disease
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
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
Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma
A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety…
- Trial name
- NCT02900664
- Testing
- PDR001, ACZ885, CJM112
- Where
- 23 sites in United States, Belgium and 7 more
- Volunteers
- 283 people
- Sponsor
- Novartis Pharmaceuticals
Urothelial Carcinoma, Triple Negative Breast Cancer
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4…
- Conditions
- Urothelial Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT05234606
- Testing
- SBT6290, pembrolizumab
- Sponsor
- Silverback Therapeutics
HER2-expressing Cancers
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety…
- Trial name
- NCT03821233
- Testing
- ZW49
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 112 people
- Sponsor
- Zymeworks BC Inc.
Advanced Solid Tumor, Lymphoma
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study.
- Conditions
- Advanced Solid Tumor, Lymphoma, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT04106167
- Testing
- Allogeneic natural killer (NK) cell
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Fate Therapeutics
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
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)
Advanced Solid Tumor
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.
- Trial name
- CVL009-C2001 (NCT06519110)
- Testing
- Neratinib tablets
- Volunteers
- 60 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
NON-SMALL CELL LUNG CANCER
Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients
This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with HER2 gene mutation, pretreated with at least…
- Trial name
- NCT00758134
- Testing
- Trastuzumab (Herceptin)
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- Armando Santoro, MD