Clinical Trials for Breast Cancer

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 (including a broad range such as ovarian, pancreatic, GI, lung, and more) or relapsed/refractory multiple myeloma who have failed or are intolerant to standard therapies are eligible to receive QXL138AM, a masked anti-CD138 immunocytokine fused to interferon alpha-2a designed for tumor-targeted immune activation.

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: This trial enrolls adults with advanced or metastatic solid tumors, particularly breast cancer and CCNE1-amplified tumors, who are refractory to or intolerant of standard therapies, to receive NKT5097, a novel oral degrader targeting CDK2 and CDK4 for inhibition of cell cycle progression. All participants must have measurable or evaluable disease, ECOG 0-1, adequate organ function, and no active CNS metastases.

ClinicalTrials.gov ID: NCT07029399

Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

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

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 HR+, HER2-negative metastatic breast cancer and PI3K pathway alterations (PIK3CA, PTEN, AKT1) to receive triplet therapy with fulvestrant, a PI3K (alpelisib) or AKT (capivasertib) inhibitor, and evexomostat—a MetAP2 inhibitor with anti-angiogenic and metabolic effects—while assessing both cancer response and metabolic side effects such as hyperglycemia.

ClinicalTrials.gov ID: NCT05455619

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: Eligible patients are adults with metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell lung cancer, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer that has progressed after standard therapies; participants must have measurable disease, adequate organ function, and be willing to undergo tumor biopsy. Patients will receive intravenous SLV-154 (mechanism and target undisclosed) in 3-week cycles at escalating doses to determine safety and dosing parameters.

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 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing 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: This trial enrolls adults with recurrent or metastatic GRPR-expressing solid tumors (including mCRPC, HR+/HER2- breast, colorectal, cervical, melanoma, and NSCLC) who have progressed on at least two prior systemic therapies, and treats them with 212Pb-DOTAM-GRPR1, a radiolabeled peptide that targets the gastrin-releasing peptide receptor (GRPR) to deliver alpha particle radiation directly to tumor cells.

ClinicalTrials.gov ID: NCT05283330

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: This trial enrolls adults with locally advanced or metastatic solid tumors, including those with platinum-resistant or refractory high-grade serous ovarian cancer, who have failed or are unsuitable for standard therapies. Patients receive oral ATX-295, a selective inhibitor of the mitotic kinesin KIF18A designed to induce mitotic arrest and tumor cell death.

ClinicalTrials.gov ID: NCT06799065

A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced and/or Metastatic 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: This trial enrolls adults with advanced or metastatic HR+/HER2- breast cancer who have progressed on prior endocrine and CDK4/6 inhibitor therapies, excluding those with RB1 mutations or symptomatic visceral/CNS metastases. Patients receive BTX-9341, an oral bifunctional CDK4/6 degrader, as monotherapy or in combination with fulvestrant.

ClinicalTrials.gov ID: NCT06515470