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
Biliary Tract Cancer (BTC), EGFR-positive Advanced Biliary Tract Carcinoma
Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II
Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.
- Trial name
- NCT07649980
- Testing
- Becotatug Vedotin, Pucotenlimab
- Volunteers
- 30 people
- Sponsor
- HuiKai Li
Cutaneous Squamous Cell Carcinoma (CSCC)
Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma
Study Design The study plans to enroll 38 patients. A Simon's two-stage design is employed. Based on historical data, the objective response rate (ORR) for patients meeting the inclusion criteria and receiving PD-1 inhibitor…
- Trial name
- NCT07394244
- Testing
- Pucotenlimab, Becotatug Vedotin
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Fudan University
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.
Head and Neck Squamous Cell Carcinoma
A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma
A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC).
- Trial name
- NCT06509997
- Testing
- MRG003 combined with Dalpicicilip
- Volunteers
- 30 people
- Sponsor
- Lei Liu
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
Cholangiocarcinoma
The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma
(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects.
- Trial name
- NCT07514533
- Testing
- Vibecototamab（iv）+Putilimab（iv）
- Volunteers
- 60 people
- Sponsor
- Sir Run Run Shaw Hospital
Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC
Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck…
- Trial name
- NCT07393477
- Testing
- Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sir Run Run Shaw Hospital
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.
Head and Neck Squamous Cell Carcinoma
A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck…
- Trial name
- NCT07381075
- Testing
- Becotatug Vedotin, Becotatug Vedotin Combined with Penpulimab, Becotatug Vedotin Combined with Ivonescimab
- Where
- China
- Volunteers
- 90 people
- Sponsor
- West China Hospital
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
Head and Neck Squamous Cell Carcinoma
Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study
This is a prospective, single-arm, multi-center, Phase II clinical trial evaluating the efficacy and safety of neoadjuvant becotatug vedotin (an anti-EGFR antibody-drug conjugate) combined with pucotenlimab (HX008, an anti-PD-1…
- Trial name
- GATEWAY (NCT07589049)
- Testing
- Becotatug Vedotin, Pucotenlimab
- Where
- 12 sites in China
- Volunteers
- 42 people
- Sponsor
- Sun Yat-sen University
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.
Oral Squamous Cell Carcinoma, Head and Neck Cancer
Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma
This is a phase 2, open-label, single-arm clinical trial evaluating neoadjuvant therapy with Becotatug vedotin (MRG003) combined with Pucotenlimab (HX008) in patients with previously untreated, resectable stage III-IVA oral…
- Conditions
- Oral Squamous Cell Carcinoma, Head and Neck Cancer, Locally Advanced Head and Neck Cancer, Neoadjuvant Therapy
- Trial name
- NCT07766889
- Testing
- Becotatug Vedotin (MRG003), Pucotenlimab
- Where
- 2 sites in China
- Volunteers
- 32 people
- Sponsor
- Sun Yat-sen University
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
Lung Cancer (NSCLC), EGFR Activating Mutation
First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations
To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+/2+/3+)
- Conditions
- Lung Cancer (NSCLC), EGFR Activating Mutation, HER2
- Trial name
- NCT07699952
- Testing
- Almonertinib, Trastuzumab Rezetecan
- Volunteers
- 35 people
- Sponsor
- Yongsheng Wang
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.
Penile Cancer
MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma
Penile squamous cell carcinoma (PSCC) is a rare malignancy, with stage IV patients exhibiting a 2-year overall survival (OS) rate of 21% and a 5-year survival rate of 0%.
- Trial name
- MH-Penile-001 (NCT07054307)
- Testing
- MRG003, HX008
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Jiyan Liu