Clinical trials: HER2-positive Solid Tumor
NSCLC, SCLC
Study of Oral MRT-2359 in Selected Cancer Patients
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer…
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL
- Trial name
- NCT05546268
- Testing
- Oral MRT-2359
- Where
- 17 sites in United States
- Volunteers
- 174 people
- Sponsor
- Monte Rosa Therapeutics, Inc
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
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 Tumor
Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006
Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- Trial name
- NCT05414136
- Testing
- BAT1006
- Where
- 2 sites in China
- Volunteers
- 37 people
- Sponsor
- Bio-Thera Solutions
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 Tumor
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced…
- Trial name
- NCT06241456
- Testing
- FT825, Fludarabine, Cyclophosphamide
- Where
- 14 sites in United States
- Volunteers
- 351 people
- Sponsor
- Fate Therapeutics
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
- 66 sites in United States, China and 1 more
- Volunteers
- 952 people
- Sponsor
- Genmab
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
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.
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
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
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
Breast Cancer, Gastric Cancer
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic…
- Conditions
- Breast Cancer, Gastric Cancer, Solid Tumors, NSCLC
- Trial name
- NCT02500199
- Testing
- Pyrotinib
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- Hengrui Therapeutics, Inc.
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
HER2 Positive Gastric Cancer, Colorectal Cancer
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: Regimen A: FATE-NK100 as a monotherapy in subjects with advanced…
- Conditions
- HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, EGFR Positive Solid Tumor
- Trial name
- NCT03319459
- Testing
- FATE-NK100, Cetuximab, Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Fate Therapeutics
Breast Neoplasms
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in…
- Trial name
- NCT03284723
- Testing
- PF-06804103, PF-06804103 + Palbociclib +Letrozole
- Where
- 46 sites in United States, Australia and 4 more
- Volunteers
- 95 people
- Sponsor
- Pfizer
HER2-positive Solid Tumors
A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are…
- Trial name
- NCT06806982
- Testing
- VRN101099
- Where
- Australia
- Volunteers
- 72 people
- Sponsor
- Voronoi, 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.