Clinical Trials for Breast Cancer

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced or metastatic TP53 R175H-mutant solid tumors who are HLA-A*02:01-positive and have exhausted standard options receive CLSP-1025 monotherapy. This investigational T-cell engager binds CD3 and an HLA-A*02:01-presented mutant p53 peptide to direct T-cell killing of tumor cells.

ClinicalTrials.gov ID: NCT06778863

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Eligible patients are adults with metastatic, refractory gastrointestinal, hepatobiliary, genitourinary, breast, ovarian, endometrial, or selected endocrine/neuroendocrine tumors who have failed standard therapies and have a resectable lesion for TIL generation. Treatment includes lymphodepleting chemotherapy, autologous tumor-infiltrating lymphocyte (TIL) infusion, high-dose aldesleukin, and pembrolizumab, a PD-1 immune checkpoint inhibitor, with timing of pembrolizumab varying by study arm.

ClinicalTrials.gov ID: NCT01174121

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with metastatic or recurrent breast adenocarcinoma of any subtype (ER/PR+, HER2+, or triple negative) who have progressed on standard therapies, to receive intratumoral injections of MV-s-NAP, an oncolytic measles virus engineered to express neutrophil-activating protein, aimed at inducing tumor cell lysis and immune activation. Treatment is administered directly into tumor lesions, with eligibility requiring adequate organ function and performance status.

ClinicalTrials.gov ID: NCT04521764

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with advanced, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced breast cancer that has progressed after approved treatment, or for whom no standard therapy is available, receive oral MBQ-167 twice daily in a dose-escalation study. MBQ-167 inhibits the Rac and Cdc42 GTPases; its clinical safety and efficacy remain undetermined.

ClinicalTrials.gov ID: NCT06075810

SHARON: Study of Metastatic Cancers in Patients With a Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with metastatic pancreatic (ductal or acinar) or HER2-negative breast cancer harboring BRCA1, BRCA2, or PALB2 mutations, and treats them with high-dose melphalan and BCNU in combination with vitamin B12b, escalating doses of vitamin C, and low-dose ethanol, followed by autologous hematopoietic stem cell rescue. The investigational regimen aims to overcome drug resistance in homologous recombination-deficient tumors by exploiting oxidative stress pathways.

ClinicalTrials.gov ID: NCT04150042

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced, measurable solid tumors and ECOG performance status 0–1 receive intravenous TUB-030 every three weeks; dose-optimization cohorts are limited to NSCLC and HNSCC. TUB-030 is an investigational 5T4-targeting antibody–drug conjugate that delivers exatecan, a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06657222

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced HR-positive, HER2-negative breast cancer that has progressed after endocrine therapy and a CDK4/6 inhibitor receive the investigational CDK2 inhibitor ECI830 alone or with ribociclib and fulvestrant; combination arms are also compared with ribociclib plus fulvestrant. Phase I additionally enrolls patients with other advanced CCNE1-amplified solid tumors.

ClinicalTrials.gov ID: NCT06726148

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with incurable advanced breast cancer who have received endocrine therapy and progressed on a CDK4/6 inhibitor plus fulvestrant or an aromatase inhibitor receive oral MEN2312, an investigational KAT6A/KAT6B inhibitor, alone or with elacestrant, an oral estrogen-receptor degrader.

ClinicalTrials.gov ID: NCT06638307

Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic triple-negative breast cancer after at least two prior systemic treatment lines for advanced disease, and no prior gemcitabine for metastatic disease, receive intravenous ProAgio plus gemcitabine. ProAgio is an investigational cytotoxin targeting integrin αvβ3 on tumor-associated fibroblasts and vascular cells.

ClinicalTrials.gov ID: NCT06460298