Clinical Trials for Breast Cancer

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected 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 study enrolls adults with advanced or metastatic solid tumors (including selected breast, gynecologic, and gastrointestinal cancers) who have progressed on or are ineligible for standard therapies, investigating INCB123667 (mechanism unknown) as monotherapy or in combination with agents such as palbociclib, ribociclib, fulvestrant, bevacizumab, olaparib, or paclitaxel. Patients must have good performance status (ECOG 0-1), and the trial includes tumor-specific expansion cohorts.

ClinicalTrials.gov ID: NCT05238922

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) 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.

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 metastatic solid tumors (such as pancreatic, colorectal, and breast cancers) who have progressed after standard therapies, as well as adolescents (12–17 years) with solid tumors lacking standard options (excluding rhabdomyosarcoma), to receive oral metarrestin, a first-in-class small molecule that targets the perinucleolar compartment to disrupt ribosome biogenesis and inhibit metastasis.

ClinicalTrials.gov ID: NCT04222413

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

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

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 metastatic or refractory/recurrent KK-LC-1 positive epithelial cancers (including gastric, breast, cervical, lung, and others) who are also HLA-A*01:01 positive and have adequate organ function. Patients receive lymphodepleting chemotherapy followed by a single infusion of autologous T cells genetically engineered to express a TCR targeting the cancer germline antigen KK-LC-1, along with high-dose aldesleukin to support T cell activity.

ClinicalTrials.gov ID: NCT05035407

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

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma

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 indolent non-Hodgkin’s lymphoma (excluding aggressive subtypes), metastatic breast cancer, or head and neck squamous cell carcinoma who have peripherally accessible tumors, and tests intratumoral Flt3L (dendritic cell growth factor) and poly-ICLC (TLR3 agonist) plus low-dose local radiation combined with systemic pembrolizumab (PD-1 inhibitor). Patients may have had prior PD-1/PD-L1 therapy, and the regimen aims to enhance local and systemic anti-tumor immune responses.

ClinicalTrials.gov ID: NCT03789097