Clinical trials: HER2+ Breast Cancer
ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Trial name
- CYCAD-1 (NCT06188520)
- Testing
- AZD8421, Camizestrant, Ribociclib
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer
A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer.
- Trial name
- NCT06891833
- Testing
- BL-M07D1, Pertuzumab, docetaxel
- Where
- 30 sites in China
- Volunteers
- 985 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Breast Cancer; HER2-positive; Metastatic
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2…
- Trial name
- NCT04784715
- Testing
- Trastuzumab deruxtecan, Taxane, Pertuzumab
- Where
- 283 sites in United States, Argentina and 25 more
- Volunteers
- 1,157 people
- Sponsor
- AstraZeneca
Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors.
- Trial name
- NCT07287917
- Testing
- AMXT 1501 Dicaprate, DFMO, Fulvestrant
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Aminex Therapeutics, Inc.
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer
Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer
The primary objective of this expanded access program (EAP) is to provide early access to giredestrant for participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast…
- Trial name
- NCT07643831
- Testing
- Giredestrant
- Where
- 9 sites in United States
- Sponsor
- Genentech, Inc.
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination…
- Conditions
- Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- KAT6 (NCT04606446)
- Testing
- PF-07248144, Fulvestrant, Letrozole
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer
MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)
This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate…
- Trial name
- NCT07885683
- Testing
- The MagSense® HER2 Imaging Agent (MSH2IA)
- Volunteers
- 70 people
- Sponsor
- Imagion Biosystems, Inc.
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
Advanced HR+/HER2- Breast Cancer
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone…
- Trial name
- NCT07604571
- Testing
- IEV407, Fulvestrant, Letrozole
- Where
- 10 sites in United States, Canada and 5 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
ER-Positive HER2-Negative Breast Cancer
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced…
- Trial name
- SERAFA-1 (NCT07647328)
- Testing
- Camizestrant, Ribociclib
- Where
- 89 sites in United States, France and 7 more
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors (Phase 1), HNSCC
MTX-531-001 Phase 1 Study in Advanced Solid Tumors
This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors.
- Conditions
- Solid Tumors (Phase 1), HNSCC, Endometrial Cancer, Her2-negative Metastatic Breast Cancer
- Trial name
- NCT07874880
- Testing
- MTX-531
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- MEKanistic Therapeutics, Inc.
Advanced Solid Tumor, Locally Advanced Solid Tumor
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2…
- Conditions
- Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer
- Trial name
- IL Believe (NCT05081609)
- Testing
- TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug
- Where
- 68 sites in United States, Australia and 8 more
- Volunteers
- 320 people
- Sponsor
- Ascendis Pharma Oncology Division A/S