Clinical Trials for Breast Cancer

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally As Monotherapy and in Combination to Patients with 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors—especially those with DNA damage response gene defects—evaluating ART6043, an oral DNA polymerase theta inhibitor, as monotherapy or in combination with PARP inhibitors (olaparib or niraparib), with particular focus in later phases on patients with HER2-negative, BRCA-mutated, locally advanced or metastatic breast cancer.

ClinicalTrials.gov ID: NCT05898399

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

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—specifically metastatic triple-negative or HR+/HER2- breast cancer after progression—testing the combination of sacituzumab govitecan and Invikafusp alfa (STAR0602), a novel bispecific antibody that targets and activates Vβ6/Vβ10 TCR-expressing T cells to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT06827613

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-559, an Oral Inhibitor of the Helicase DHX9, in Patients With Locally Advanced or Metastatic Solid Tumors and Molecularly Defined 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.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors refractory to standard therapies, with expansion cohorts for BRCA1/2-deficient, HER2-negative metastatic breast cancer and unresectable/metastatic dMMR or MSI-H tumors, to evaluate the safety and early efficacy of ATX-559, a first-in-class oral DHX9 helicase inhibitor.

ClinicalTrials.gov ID: NCT06625515

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, 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.

HealthScout AI summary: Eligible patients are adults with advanced, refractory solid tumors of any histology (including those with stable, treated CNS metastases) and good performance status. The trial evaluates LCB84, a TROP2-targeted antibody-drug conjugate delivering MMAE, given alone or in combination with an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05941507

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

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 advanced or metastatic solid tumors (including expansion cohorts for triple-negative breast cancer or gastric/gastroesophageal junction cancer) refractory to standard therapies, and patients with relapsed/refractory acute myeloid leukemia, to evaluate the safety and preliminary efficacy of BAL0891, a dual TTK/PLK1 mitotic checkpoint inhibitor, as monotherapy or in combination with carboplatin or paclitaxel.

ClinicalTrials.gov ID: NCT05768932

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- 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.

HealthScout AI summary: Eligible patients are adults with HR+/HER2- metastatic breast cancer who have progressed on at least two prior lines of therapy (including both endocrine therapy and a CDK4/6 inhibitor) and will receive BGB-21447, a selective oral Bcl-2 inhibitor, in combination with fulvestrant with or without the investigational oral CDK4 inhibitor BGB-43395. Both postmenopausal women and men with good performance status and adequate organ function may enroll.

ClinicalTrials.gov ID: NCT06756932

Multicenter Phase I/Ib Trial of Olaparib in Combination with Vorinostat in Patients with Relapsed/Refractory And/or Metastatic Breast Cancer

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 relapsed/refractory or metastatic, HER2-negative breast cancer to receive a combination of olaparib (a PARP inhibitor targeting DNA repair) and vorinostat (a histone deacetylase inhibitor) to assess safety, tolerability, and preliminary efficacy. Prior treatment with PARP or HDAC inhibitors is not allowed, and participants require good performance status and adequate organ function.

ClinicalTrials.gov ID: NCT03742245