Clinical Trials for Breast Cancer

A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer

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: Enrolls adults with measurable relapsed/refractory triple-negative breast cancer (ER/PR <10%, HER2–) after at least one prior standard regimen (including chemo/immunotherapy and ADCs as applicable), ECOG 0–2; stable treated brain metastases allowed. Patients receive IV CLR 125, an iodine-125–labeled phospholipid ether tumor-targeted radiotherapeutic that accumulates in tumor membranes to deliver short-range Auger-electron radiation, given as 4 fractionated doses per 8-week cycle with dose-level cohorts; an optional sub-study gives a single imaging dose of iopofosine I-131 (CLR 131) for dosimetry.

ClinicalTrials.gov ID: NCT07311993

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

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: For adults with ECOG 0–1 and measurable unresectable/metastatic disease, this study enrolls either ER+/HER2− breast cancer with actionable PIK3CA/AKT1/PTEN alterations after progression on ≥2 endocrine-based regimens (candidate for fulvestrant + capivasertib) or cutaneous melanoma progressing after prior immune checkpoint inhibitor therapy (and after/intolerant to BRAF/MEK inhibitors if BRAF V600–mutant). Patients receive dual polyamine blockade with oral AMXT 1501 (polyamine transport inhibitor) plus oral DFMO/eflornithine (irreversible ornithine decarboxylase inhibitor) added to standard therapy—fulvestrant + capivasertib in breast cancer or pembrolizumab in melanoma.

ClinicalTrials.gov ID: NCT07287917

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing 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: Enrolling adults with locally advanced/unresectable or metastatic HER2-expressing solid tumors (dose escalation includes HER2+ and breast cancer across HER2-positive/low/ultralow; expansion limited to HER2-low breast cancer [IHC 1+ or 2+/ISH−] or HR+ HER2-ultralow) who have had at least one prior cytotoxic chemotherapy line and have ECOG ≤2, adequate organ function, and LVEF ≥50% (selected stable/treated brain metastases allowed; ILD/pneumonitis risk excluded). Treatment is single-arm trastuzumab deruxtecan IV day 1 every 21 days plus pidnarulex (CX-5461; investigational G-quadruplex–stabilizing DNA-damage/DDR-targeting agent) IV day 8, continued until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07137416

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

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.

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: Adults with advanced solid tumors or metastatic breast cancer (arm-specific eligibility, some requiring HER2 expression or prior HER2 therapy) receive investigational combinations including evorpacept (CD47/SIRPα blocker) plus trastuzumab deruxtecan, or zanidatamab (bispecific anti‑HER2) plus tucatinib (HER2 TKI), with dose-finding and expansion to assess safety and preliminary activity. Arms may prioritize patients previously treated with HER2-directed therapies, including T-DXd.

ClinicalTrials.gov ID: NCT05868226

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

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.

TrialFetch AI summary: The INSIGHT trial investigates early chemotherapy with capecitabine versus endocrine-based therapy in patients with non-Luminal A hormone receptor-positive metastatic breast cancer who have previously been treated with aromatase inhibitors, CDK4/6 inhibitors, or selective estrogen receptor modulators/downregulators, but not chemotherapy in the metastatic setting. The study aims to evaluate the anti-tumor effects, safety, and tolerability of these treatments while assessing cfDNA mutations as early indicators of response and potential genomic alterations linked to treatment resistance.

ClinicalTrials.gov ID: NCT05693766

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

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.

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: This trial enrolls adult patients with advanced solid tumors, including NSCLC, who have progressed after anti-PD-1/PD-L1 therapy to evaluate MEM-288, an oncolytic adenovirus with immunostimulatory properties, alone and in combination with the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT05076760

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

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.

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: This trial targets adult patients with advanced solid malignancies and evaluates the safety and efficacy of CRX100, an investigational immunotherapy combining autologous T cells and oncolytic vaccinia virus, as monotherapy and in combination with Pembrolizumab.

ClinicalTrials.gov ID: NCT04282044

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

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.

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: The trial enrolls adults with measurable ovarian, endometrial, triple-negative breast, or non-small cell lung cancers to evaluate the safety and efficacy of Farletuzumab Ecteribulin (MORAb-202), an antibody-drug conjugate targeting folate receptor alpha, which delivers eribulin to cancer cells.

ClinicalTrials.gov ID: NCT04300556

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents 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.

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: This trial investigates GSK4381562, a monoclonal antibody targeting PVRIG to enhance NK and T cell activation, as monotherapy and in combination with anticancer agents such as dostarlimab, belrestotug, nelistotug, and GSK5764227 in patients with advanced solid tumors who lack standard treatment options. Eligible participants have locally recurrent or metastatic solid tumors, have progressed after standard therapies, and possess an ECOG performance status of 0-1 with adequate organ function.

ClinicalTrials.gov ID: NCT05277051

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

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.

TrialFetch AI summary: This trial targets adults with breast cancer or NSCLC with leptomeningeal metastases, using craniospinal irradiation with hippocampal avoidance via proton or VMAT to reduce neurological side effects while effectively treating the cancer. Participants require a KPS of ≥ 60 and suitable blood counts, and treatment is given over two weeks.

ClinicalTrials.gov ID: NCT06518057