Clinical trials: EGFR ADC
Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
Locally Advanced (Unresectable) or Metastatic Solid Tumors
A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors
This is a first in human (FIH), Phase 1 dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).
- Trial name
- NCT07612189
- Testing
- NEOK002, NEOK002 RDE
- Where
- 10 sites in United States
- Volunteers
- 155 people
- Sponsor
- NEOK Bio, Inc.
Non-Small Cell Lung Cancer
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)
The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or…
- Trial name
- NCT07680790
- Testing
- Iza-bren, Osimertinib, Pemetrexed
- Where
- 204 sites in United States, Argentina and 14 more
- Volunteers
- 850 people
- Sponsor
- Bristol-Myers Squibb
Metastatic Breast Cancer
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow…
- Trial name
- NCT07757230
- Testing
- SSGJ-612 (HER2-targeted antibody), HER2-targeted ADC
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
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
Solid Tumor and NSCLC
A Study of HLX42 in Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
- Trial name
- NCT06210815
- Testing
- HLX42
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Shanghai Henlius Biotech
Non-Small-Cell Lung Cancer
CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
- Trial name
- NCT04681131
- Testing
- CAB-AXL-ADC, PD-1 inhibitor
- Where
- 60 sites in United States, Greece and 5 more
- Volunteers
- 85 people
- Sponsor
- BioAtla, Inc.
Non-Small Cell Lung Cancer
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Trial name
- DESTINY-Lung01 (NCT03505710)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 181 people
- Sponsor
- Daiichi Sankyo
Endometrial Cancer, Ovarian Cancer
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid…
- Conditions
- Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent
- Trial name
- NCT07444814
- Testing
- HWK-007
- Where
- 12 sites in United States
- Volunteers
- 226 people
- Sponsor
- Whitehawk Therapeutics, Inc.
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04838964
- Testing
- MRG003
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Solid Tumors, Non-Small Cell Lung Cancer
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other…
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- HS-20117 (NCT06621563)
- Testing
- HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy, HS-20117 combined HS-20093 and 5-FU
- Where
- China
- Volunteers
- 780 people
- Sponsor
- Hansoh BioMedical R&D Company
Non-small Cell Lung Cancer (NSCLC)
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR…
- Trial name
- NCT06074588
- Testing
- Sacituzumab tirumotecan, Docetaxel, Pemetrexed
- Where
- 195 sites in United States, Australia and 23 more
- Volunteers
- 556 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumor
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or…
- Trial name
- NCT07070232
- Testing
- BNT326, Pumitamig, Itraconazole
- Where
- 77 sites in United States, Australia and 7 more
- Volunteers
- 1,438 people
- Sponsor
- BioNTech SE
Locally Advanced Breast Cancer, Unresectable Breast Carcinoma
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination…
- Conditions
- Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06827236
- Testing
- BNT323, BNT327
- Where
- 81 sites in United States, Australia and 9 more
- Volunteers
- 380 people
- Sponsor
- BioNTech SE
Non-small Cell Lung Cancer
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well…
- Trial name
- NCT07111520
- Testing
- BNT326, Pumitamig
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 880 people
- Sponsor
- BioNTech SE
Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Carcinoma
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
- Trial name
- NCT05188209
- Testing
- MRG003
- Where
- 5 sites in China
- Volunteers
- 6 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Breast Cancer
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and…
- Trial name
- NCT03529110
- Testing
- Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
- Where
- 164 sites in United States, Australia and 13 more
- Volunteers
- 524 people
- Sponsor
- Daiichi Sankyo
Carcinoma, Non-Small-Cell Lung
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer
- Trial name
- NCT04838548
- Testing
- MRG003
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Advanced Solid Tumors
A Study of HDM2024 in Participants With Advanced Solid Tumors
The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are: Is the drug safe and tolerable ? Does the drug exhibit antitumor activity ?…
- Trial name
- NCT07539285
- Testing
- HDM2024
- Where
- China
- Volunteers
- 63 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.