Clinical trials: HER2-expressing Advanced Solid Tumors
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.
Solid Tumors
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human…
- Trial name
- NCT03448042
- Testing
- Runimotamab, Trastuzumab, Tocilizumab
- Where
- 26 sites in United States, Australia and 11 more
- Volunteers
- 123 people
- Sponsor
- Genentech, Inc.
Endometrial Cancer, Cervical Cancer
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
- Conditions
- Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma
- Trial name
- NCT06293898
- Testing
- BL-M07D1
- Where
- 26 sites in United States
- Volunteers
- 280 people
- Sponsor
- SystImmune Inc.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Solid Tumor, Advanced Lung Cancer
IMM2902 in Patients With Advanced Solid Tumors Expressing HER2
This trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing…
- Conditions
- Advanced Solid Tumor, Advanced Lung Cancer, Advanced Gastric Carcinoma, Advanced Cholangiocarcinoma
- Trial name
- NCT05805956
- Testing
- IMM2902
- Where
- 2 sites in China
- Volunteers
- 105 people
- Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) 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.
Advanced Solid Tumor
A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor…
- Trial name
- NCT05819684
- Testing
- SHR-4602 for injection
- Where
- China
- Volunteers
- 133 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Advanced Solid Tumor, Advanced Breast Cancer
IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors
This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Gastric Cancer
- Trial name
- NCT05076591
- Testing
- IMM2902
- Where
- 3 sites in United States
- Volunteers
- 135 people
- Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Locally Advanced/Metastatic HER2 Positive Solid Tumors
A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors
This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors.
- Trial name
- NCT04257110
- Testing
- BB-1701
- Where
- 12 sites in United States, China
- Volunteers
- 117 people
- Sponsor
- Bliss Biopharmaceutical (Hangzhou) Co., Ltd
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
Receptor, ErbB-2
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous…
- Trial name
- NCT05145179
- Testing
- SSGJ-705
- Volunteers
- 162 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Breast Cancer
A Study of A166 in Patients With Advanced Solid Malignant Tumors
This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
- Trial name
- NCT05311397
- Testing
- A166
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or…
- Trial name
- NCT06271837
- Testing
- Trastuzumab deruxtecan, Bevacizumab
- Where
- 29 sites in China
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
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.
Locally Advanced Solid Tumor, Metastatic Cancer
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer
- Trial name
- NCT04319757
- Testing
- ACE1702, Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 12 people
- Sponsor
- Acepodia Biotech, Inc.
Advanced Solid Tumors
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor…
- Trial name
- NCT04446260
- Testing
- SHR-A1811
- Where
- 35 sites in United States, Australia and 3 more
- Volunteers
- 396 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumor
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
- Trial name
- NCT04162327
- Testing
- IBI315
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
HER2-Expressing Advanced Solid Tumors, HER2-Mutated Advanced Solid Tumors
A First-in-human Study of SMP-656 in Subjects With Locally Advanced/ Metastatic HER2 Expressing or Mutated Solid Tumors
This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of SMP-656 in subjects with locally advanced/metastatic HER2 expressing or HER2-mutated solid tumors.
- Conditions
- HER2-Expressing Advanced Solid Tumors, HER2-Mutated Advanced Solid Tumors, Metastatic Solid Tumors
- Trial name
- NCT07922096
- Testing
- SMP-656 Injection
- Where
- 5 sites in China
- Volunteers
- 35 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4…
- Conditions
- Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms
- Trial name
- NCT04561362
- Testing
- BT8009, Pembrolizumab
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 329 people
- Sponsor
- BicycleTx Limited