Clinical Trials for Breast Cancer

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

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

HealthScout AI summary: This trial enrolls adults with metastatic triple-negative breast cancer and metabolic dysfunction (HbA1c > 5.5% and/or BMI ≥ 30) who have had up to two prior metastatic therapies, randomizing them to eribulin with either placebo or evexomostat, a polymer-conjugated MetAP2 inhibitor with anti-angiogenic and metabolic modulatory effects. Key exclusions include uncontrolled diabetes and significant cardiac disease.

ClinicalTrials.gov ID: NCT05570253

An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients 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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors (any histology) who have progressed on or are unsuitable for standard therapies and have measurable disease, regardless of tumor FRα or TRPV6 status. Patients receive IV CBP-1019, a bi-ligand-drug conjugate that targets Folate Receptor alpha and TRPV6 to deliver a topoisomerase I inhibitor directly to tumor cells.

ClinicalTrials.gov ID: NCT05830097

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant 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.

HealthScout AI summary: Eligible patients are adults with advanced, HER2-expressing solid tumors (including gynecologic, urothelial, biliary tract, breast, lung, and gastrointestinal cancers) who have progressed after at least two prior lines of standard therapy. All participants receive BL-M07D1, an investigational HER2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (Ed-04) selectively to tumor cells via IV infusion every 21 days.

ClinicalTrials.gov ID: NCT06293898

A Study of PARG Inhibitor IDE161 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With 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.

HealthScout AI summary: This trial involves adult patients with advanced solid malignancies, evaluating the safety and efficacy of the PARP inhibitor AZD5305, both alone and combined with agents like Paclitaxel and Trastuzumab Deruxtecan, showing promising response rates and reduced hematologic toxicity.

ClinicalTrials.gov ID: NCT04644068

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.

HealthScout 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-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive 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.

HealthScout AI summary: This trial enrolls adult patients with HER2-positive advanced/unresectable or metastatic solid tumors that are relapsed or refractory to standard therapies, administering GQ1001, an antibody-drug conjugate targeting HER2 by combining trastuzumab with DM1. The study seeks to establish the safety and efficacy of escalating doses of GQ1001, with common adverse events including elevated liver enzymes, thrombocytopenia, and fever.

ClinicalTrials.gov ID: NCT04450732