Clinical Trials for Breast Cancer

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With 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.

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.

HealthScout AI summary: This trial enrolls adults with advanced, measurable solid tumors (including separate cohorts for breast, pancreatic, or gastric cancer) who have progressed after standard therapy, testing Minnelide—a prodrug of triptolide that inhibits HSP70 with downstream anti-oncogenic effects—given alone or in combination with protein-bound paclitaxel. Patients must have good performance status and adequate organ function.

ClinicalTrials.gov ID: NCT03129139

Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ 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.

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.

HealthScout AI summary: This trial enrolls adults with RSK2-positive, HR+/HER2- locally advanced or metastatic breast cancer who have progressed after CDK4/6 inhibitor plus endocrine therapy, testing the investigational oral RSK inhibitor PMD-026 (which targets all four RSK isoforms in the MAPK/PDK-1 pathway) as monotherapy and in combination with fulvestrant. Eligible patients must provide tumor tissue for RSK2 analysis and have measurable disease.

ClinicalTrials.gov ID: NCT04115306

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

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.

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.

HealthScout AI summary: Adults with advanced or metastatic solid tumors that are refractory to, have progressed after, or are intolerant to standard therapies may receive oral AMXI-5001, a novel dual PARP1/2 and microtubule polymerization inhibitor, as monotherapy in this open-label study. Participants must have ECOG 0-1 and measurable or evaluable disease; no concurrent cancer therapy or strong CYP3A4 modulators are allowed.

ClinicalTrials.gov ID: NCT04503265

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the Bone All Eligible)

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.

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.

HealthScout AI summary: This trial enrolls patients aged 15–75 with solid tumors metastatic to bone or primary bone tumors and measurable disease, treating them with two tandem doses of CycloSam® (153-Sm-DOTMP), a bone-targeted radiopharmaceutical that delivers localized beta/gamma radiation to osteoblastic lesions. The study requires prior stem cell collection for hematologic rescue and excludes patients with prior radiotherapy to all disease sites.

ClinicalTrials.gov ID: NCT06008483