Clinical Trials for Breast Cancer

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

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 HER2-positive breast cancer and confirmed leptomeningeal disease (with or without brain metastases), who will receive radiation therapy followed by intrathecal trastuzumab (HER2-targeted antibody) and dose-escalated intrathecal pertuzumab (HER2 dimerization inhibitor) via an Ommaya reservoir. Patients must have adequate organ function and the ability to undergo Ommaya placement; prior therapies are allowed.

ClinicalTrials.gov ID: NCT04588545

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally 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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic solid tumors—including colorectal, triple-negative breast, melanoma, and ovarian cancer—who have progressed on or cannot receive standard therapies, to receive NM1F (a PVRIG/CD112R immune checkpoint inhibitor) alone or in combination with pembrolizumab. Key exclusions are active CNS involvement, prior PVRIG/CD226-axis therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT05746897

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

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

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing 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: This trial assesses BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, both as monotherapy and combined with pembrolizumab, in patients with advanced Nectin-4 expressing solid tumors such as urothelial carcinoma, breast, NSCLC, and ovarian cancers, who have progressed after prior treatment or lack standard therapy options. The study evaluates safety, pharmacokinetics, and preliminary efficacy, with previously reported promising response rates in treated urothelial cancer patients.

ClinicalTrials.gov ID: NCT04561362

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

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: The trial investigates the use of AG01, an anti-progranulin/GP88 monoclonal antibody, in patients with relapsed or refractory advanced solid tumors, including triple negative breast cancer, hormone-resistant breast cancer, non-small cell lung cancer, and mesothelioma, who have no remaining effective treatment options. AG01 is administered biweekly to evaluate its safety, tolerability, and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05627960

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid 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: This trial involves adult patients with advanced or metastatic solid tumors such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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 or metastatic solid tumors or diffuse large B-cell lymphoma who have exhausted standard therapies, evaluating the investigational oral CBL-B inhibitor NX-1607 (which enhances antitumor immunity by blocking a negative regulator of immune cell activation) as monotherapy or in combination with paclitaxel. Eligible tumor types include ovarian, gastric, head and neck, melanoma, NSCLC, prostate, mesothelioma, triple-negative breast, urothelial, cervical, microsatellite-stable colorectal cancer, and DLBCL/Richter transformation.

ClinicalTrials.gov ID: NCT05107674

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma

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 solid tumors or lymphoma that are refractory to standard therapies, whose tumors overexpress TrkA or harbor an NTRK1 gene fusion, to receive oral VMD-928, a highly selective irreversible TrkA inhibitor that acts via allosteric dimerization and inactivation of the target. Key exclusions include significant comorbidities and impaired drug absorption.

ClinicalTrials.gov ID: NCT03556228

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