Phase 1 HER2-negative Clinical Trials

17 recruitingPhase 1

What is a Phase 1 trial?

Phase 1 trials test a new treatment in a small group of people for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects. These studies typically enroll 20 to 80 participants.

Showing 117 of 17 trials

Recruiting
Phase 1Phase 2

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

Metastatic Breast CancerHR+/HER2-negative Breast Cancer
SynDevRx, Inc.52 enrolled10 locationsNCT05455619
Recruiting
Phase 1

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

HR+/HER2-negative Breast Cancer
Totus Medicines241 enrolled18 locationsNCT05683418
Recruiting
Phase 1Phase 2

ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

Breast CancerMetastatic Breast CancerBreast Cancer Female+2 more
Sarah Sammons, MD65 enrolled1 locationNCT07198724
Recruiting
Phase 1

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer

Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Lung Non-Small Cell Carcinoma+22 more
Fred Hutchinson Cancer Center25 enrolled1 locationNCT05098210
Recruiting
Phase 1Phase 2

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

Metastatic Breast CancerHER2-negative Breast CancerAdvanced Breast Cancer+1 more
RayzeBio, Inc.124 enrolled31 locationsNCT06590857
Recruiting
Phase 1

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

Breast CancerBreast Cancer MetastaticMetastatic Breast Cancer+3 more
Memorial Sloan Kettering Cancer Center28 enrolled7 locationsNCT06678269
Recruiting
Phase 1

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

Breast Cancer MetastaticPancreatic CancerHER2-negative Breast Cancer+9 more
General Oncology, Inc.24 enrolled2 locationsNCT04150042
Recruiting
Phase 1

Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

HER2-negative Breast CancerBreast Cancer Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute18 enrolled1 locationNCT06691035
Recruiting
Phase 1

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer+4 more
Relay Therapeutics, Inc.930 enrolled37 locationsNCT05216432
Recruiting
Phase 1Phase 2

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

Inoperable Locally Advanced HER2-Negative Breast CancerMetastatic HER2-Negative Breast Cancer
Jiangsu Alphamab Biopharmaceuticals Co., Ltd180 enrolled1 locationNCT06942234
Recruiting
Phase 1

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Breast CancerHER2-negative Breast CancerBRCA1 Mutation+2 more
Dana-Farber Cancer Institute20 enrolled3 locationsNCT06488378
Recruiting
Phase 1

CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

Metastatic Breast CancerHER2-negative Breast Cancer
University of Texas Southwestern Medical Center30 enrolled7 locationsNCT05029999
Recruiting
Phase 1Phase 2

Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer

HER2-Negative Breast CarcinomaAnatomic Stage IV Breast Cancer AJCC v8
Margaret Gatti-Mays42 enrolled1 locationNCT06026657
Recruiting
Phase 1

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

Advanced Breast CancerAdvanced Prostate CancerTNBC+3 more
Jiangsu Hansoh Pharmaceutical Co., Ltd.157 enrolled1 locationNCT06769425
Recruiting
Phase 1

PRE-I-SPY Phase I/Ib Oncology Platform Program

Metastatic Breast CancerHER2-negative Breast CancerMetastatic Cancer+5 more
QuantumLeap Healthcare Collaborative124 enrolled7 locationsNCT05868226
Recruiting
Phase 1

Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy

Breast CancerHER2-negative Breast CancerHyperinsulinism
Yale University20 enrolled1 locationNCT05989347
Recruiting
Phase 1Phase 2

Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients

HER2-negative Early Breast Cancer
Peking University People's Hospital46 enrolled1 locationNCT04836156