Clinical Trials for Breast Cancer

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

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid 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.

TrialFetch AI summary: Open-label multicohort study for patients with CLDN18.2-expressing unresectable locally advanced or metastatic gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or selected other solid tumors after at least one prior systemic therapy and ECOG 0–1. Participants receive IV ASP546C every 3 weeks, a CLDN18.2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, with dose evaluation in gastroesophageal cancer and higher-dose cohorts in pancreatic and pan-tumor populations.

ClinicalTrials.gov ID: NCT07488676

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Single-arm study enrolling adults with advanced/metastatic prostate, breast, pancreatic, or NSCLC progressing after standard systemic therapy who are on opioids and can briefly defer next-line cancer treatment. Participants receive daily oral axelopran monotherapy, an investigational peripherally acting μ-opioid receptor antagonist intended to block GI opioid effects, with response assessed at about 6 weeks.

ClinicalTrials.gov ID: NCT07354919

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with previously untreated locally advanced or metastatic HR-positive/HER2-negative breast cancer and ECOG 0–1 receive letrozole plus either investigational BGB-43395, a selective CDK4 inhibitor that suppresses RB1 phosphorylation, or investigator-selected abemaciclib, palbociclib, or ribociclib.

ClinicalTrials.gov ID: NCT07492641

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