Clinical Trials for Breast Cancer

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 previously treated, recurrent unresectable, locally advanced, or metastatic EGFR-expressing solid tumors are eligible if they are germline HLA-A*02 heterozygous and their tumors have lost HLA-A*02 expression. After lymphodepleting chemotherapy, patients receive a single infusion of A2B395, an allogeneic CAR T-cell therapy designed to target EGFR-positive cells while sparing healthy cells that retain HLA-A*02.

ClinicalTrials.gov ID: NCT06682793

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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: For adults with ER-positive, HER2-negative unresectable or metastatic breast cancer that has progressed after CDK4/6 inhibitor–based endocrine therapy, this study evaluates oral RGT-419B alone or with endocrine therapy. RGT-419B inhibits CDK4 and CDK2, with CDK2 inhibition intended to address a potential mechanism of resistance to CDK4/6 inhibitors.

ClinicalTrials.gov ID: NCT05304962

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 have measurable, unresectable locally advanced or metastatic HER2-positive or HR-positive/HER2-negative breast cancer, KRAS-mutant colorectal cancer, or KRAS-mutant non-small cell lung cancer, with ECOG performance status 0–1. Treatment is oral BBO-10203, an investigational inhibitor of RAS-mediated PI3Kα activation, alone or with trastuzumab in the breast cancer cohorts.

ClinicalTrials.gov ID: NCT06625775

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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: Patients with previously treated, locally advanced or metastatic TP53 Y220C–mutant solid tumors and ECOG performance status 0–1 may be eligible; the enrolling portion requires measurable disease and excludes tumors with a KRAS single-nucleotide variant. Participants receive oral rezatapopt, an investigational small molecule that stabilizes Y220C-mutant p53 to restore tumor-suppressor activity; earlier cohorts also evaluated rezatapopt with pembrolizumab.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 solid tumors, measurable disease, and ECOG performance status 0–1 receive BMS-986507 (izalontamab brengitecan) plus either osimertinib or pembrolizumab. BMS-986507 is an EGFR/HER3-targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor; osimertinib inhibits EGFR, and pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT06618287

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 solid tumors that have progressed after standard therapy receive IV SMP-3124LP, a PEGylated liposomal CHK1 inhibitor targeting the DNA-damage response. Dose escalation includes several tumor types; expansion focuses on platinum-resistant ovarian cancer, triple-negative breast cancer, and anal squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06526819

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable advanced or metastatic ER-positive/HER2-negative breast cancer, metastatic castration-resistant prostate cancer, or non-small cell lung cancer can enter dose escalation; expansion is limited to breast cancer and prostate cancer. All participants receive oral OP-3136, a KAT6A/KAT6B histone acetyltransferase inhibitor with additional KAT7 activity, without a control arm.

ClinicalTrials.gov ID: NCT06784193

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 relapsed or refractory, unresectable locally advanced or metastatic solid tumors, including metastatic castration-resistant prostate cancer, receive MGC026 intravenously every 21 days in dose-escalation or expansion cohorts. MGC026 is a B7-H3–targeting antibody–drug conjugate carrying an exatecan-based topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 ECOG 0–1, an injectable tumor lesion, and previously treated advanced solid tumors may receive intratumoral STX-001 alone or with pembrolizumab; combination expansion cohorts focus on unresectable triple-negative breast cancer and advanced nonuveal melanoma. STX-001 is a lipid nanoparticle containing self-replicating mRNA encoding interleukin-12, designed to stimulate local antitumor immunity.

ClinicalTrials.gov ID: NCT06249048

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Patients with selected advanced solid tumors, including ovarian, fallopian tube, primary peritoneal, endometrial, cervical, non-small cell lung, triple-negative breast, pancreatic, and colorectal cancers, receive intravenous LY4170156 alone or with bevacizumab or carboplatin. LY4170156 is a folate receptor α–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06400472