Clinical Trials for Breast Cancer

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic 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 unresectable locally advanced or metastatic solid tumors who have exhausted, are ineligible for, or decline standard therapy receive IV AGX101 in dose-escalation or expansion cohorts, including a planned advanced angiosarcoma cohort. AGX101 is an antibody–drug conjugate targeting TM4SF1 on tumor cells and tumor-associated blood vessels that delivers a maytansinoid tubulin inhibitor.

ClinicalTrials.gov ID: NCT06440005

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 or huMNC2-CAR22, Specific for a Cleaved Form of MUC1 (MUC1*)

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 breast cancer whose tumors express MUC1* (≥30% of cells), who have progressed on standard therapies, to receive autologous CAR T cell therapy (huMNC2-CAR44 or huMNC2-CAR22) targeting the cleaved MUC1* isoform. Cohorts include hormone receptor positive/HER2 negative, HER2-positive, and triple negative subtypes.

ClinicalTrials.gov ID: NCT04020575

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

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 locally advanced, unresectable triple-negative breast cancer (TNBC) or recurrent, unresectable serous ovarian cancer who have not previously received CDK4/6 or HDAC inhibitors, and tests the combination of ribociclib (a CDK4/6 inhibitor) with belinostat (a pan-HDAC inhibitor). Dose escalation includes both TNBC and ovarian cancer patients, while dose expansion is limited to TNBC.

ClinicalTrials.gov ID: NCT04315233

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer Brain Metastases

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 triple negative or BRCA-mutated, HER2-negative breast cancer with new brain metastases suitable for stereotactic radiosurgery, and tests the combination of SRS with olaparib (PARP inhibitor) followed by durvalumab (PD-L1 inhibitor) plus physician’s choice single-agent systemic therapy. Patients with prior whole brain radiotherapy, diffuse leptomeningeal disease, or previous combined PARP and immune checkpoint inhibitor therapy are excluded.

ClinicalTrials.gov ID: NCT04711824

A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

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 unresectable or metastatic solid tumors after standard treatment, or multiple myeloma after at least three prior regimens including a proteasome inhibitor, IMiD, and anti-CD38 therapy, receive intravenous QXL138AM every two weeks. QXL138AM is a masked anti-CD138 antibody–interferon-alpha fusion designed to activate interferon signaling near CD138-expressing cancer cells.

ClinicalTrials.gov ID: NCT06582017

A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic 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 unresectable or metastatic solid tumors, particularly breast cancer or CCNE1-amplified tumors, receive oral NKT5097, an investigational selective CDK2/CDK4 degrader. Dose-escalation and food-effect cohorts require disease refractory to, or intolerance of, existing therapies.

ClinicalTrials.gov ID: NCT07029399

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic 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 previously treated, progressive metastatic head and neck, lung, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer receive escalating intravenous doses of SLV-154. This investigational antibody–drug conjugate is designed to deliver a cytotoxic payload to tumor cells; its specific target and payload have not been disclosed.

ClinicalTrials.gov ID: NCT06771219

Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors

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 melanoma (including prior brain metastases) or other relapsed/refractory, IL13Ralpha2-expressing solid tumors to receive lymphodepleting chemotherapy followed by systemic infusion of autologous CAR T cells targeting IL13Ralpha2, a tumor-associated antigen. Patients must have good performance status and tumors confirmed to express IL13Ralpha2 by immunohistochemistry.

ClinicalTrials.gov ID: NCT04119024

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers

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 unresectable CD70-expressing cancers (including clear cell renal cell carcinoma and other solid tumors) who have progressed after at least one prior therapy, to receive a lymphodepleting regimen followed by infusion of autologous T cells genetically engineered with an anti-CD70 chimeric antigen receptor targeting CD70-positive tumor cells, plus high-dose aldesleukin (IL-2) post-infusion.

ClinicalTrials.gov ID: NCT02830724

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian 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: Patients with locally advanced or metastatic solid tumors that have relapsed after or are refractory to standard therapy, or for whom standard therapy is unsuitable or declined, receive oral ATX-295, a KIF18A mitotic kinesin inhibitor. Expansion focuses on platinum-resistant, platinum-refractory, or platinum-intolerant high-grade serous ovarian cancer.

ClinicalTrials.gov ID: NCT06799065