Clinical Trials for Other Solid Tumor

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

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.

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.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic triple-negative breast cancer, either treatment-naïve in the metastatic setting or with one prior line of therapy, to receive BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A) in combination with standard chemotherapy agents (nab-paclitaxel, paclitaxel, gemcitabine/carboplatin, or eribulin) as first- or second-line treatment. Patients must have ECOG 0-1, measurable disease, and no significant autoimmune or comorbid conditions.

ClinicalTrials.gov ID: NCT06449222

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

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.

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.

HealthScout AI summary: This trial enrolls patients with PD-L1 positive (CPS ≥10) locally recurrent inoperable or metastatic triple-negative breast cancer, who have not received prior systemic therapy for advanced disease, to compare datopotamab deruxtecan (a TROP2-directed antibody-drug conjugate) with or without durvalumab (a PD-L1 inhibitor) versus investigator’s choice of chemotherapy plus pembrolizumab.

ClinicalTrials.gov ID: NCT06103864

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

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.

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.

HealthScout AI summary: This trial enrolls adult patients with advanced or metastatic breast cancer who have failed all standard subtype-appropriate therapies and have no remaining approved treatment options, including those with stable brain metastases. Patients are randomized to receive either physician's choice of chemotherapy or the investigational regimen of Bria-IMT (an allogeneic GM-CSF-secreting irradiated breast cancer cell line designed to stimulate anti-tumor immunity) plus low-dose cyclophosphamide, intradermal interferon-alpha, and the PD-1 inhibitor retifanlimab.

ClinicalTrials.gov ID: NCT06072612

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

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.

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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on at least one prior endocrine therapy (including a CDK4/6 inhibitor), randomizing them to sacituzumab tirumotecan (a TROP2-directed antibody-drug conjugate), sacituzumab tirumotecan plus pembrolizumab (anti-PD-1), or physician’s choice of standard single-agent chemotherapy. Key exclusions include prior chemotherapy for metastatic disease and active autoimmune conditions.

ClinicalTrials.gov ID: NCT06312176

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

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.

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.

HealthScout AI summary: This trial enrolls adults with HR-positive, HER2-negative advanced or metastatic breast cancer who have progressed on prior CDK4/6 inhibitor plus non-steroidal aromatase inhibitor therapy, excluding those with prior PI3K/AKT/mTOR inhibitor or chemotherapy for advanced disease. Patients are randomized to gedatolisib (a pan-PI3K/mTOR inhibitor) plus fulvestrant with or without palbociclib versus standard-of-care options (fulvestrant alone or alpelisib plus fulvestrant, depending on PIK3CA mutation status).

ClinicalTrials.gov ID: NCT05501886

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

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.

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic HER2-negative (HER2-low or HER2-0) breast cancer who have progressed on prior ADC therapy, including those with stable or treated CNS metastases. Patients are randomized to receive either trastuzumab deruxtecan (an anti-HER2 ADC) or datopotamab deruxtecan (an investigational anti-TROP2 ADC), with crossover permitted at progression.

ClinicalTrials.gov ID: NCT06533826

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

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.

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.

HealthScout AI summary: This trial enrolls adults with HR-positive, HER2-negative recurrent or metastatic breast cancer who have progressed after at least two prior endocrine therapies (including a CDK4/6 inhibitor) and no prior chemotherapy in the metastatic setting, to receive alisertib—an oral Aurora A kinase inhibitor—at different dose levels in combination with standard endocrine therapy. Patients must not have received prior Aurora kinase inhibitors.

ClinicalTrials.gov ID: NCT06369285

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

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.

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.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

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.

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.

HealthScout AI summary: This trial enrolls patients with HR+, HER2-low metastatic breast cancer who have progressed after endocrine therapy and have not received prior chemotherapy for metastatic disease or anti-HER2 therapy, randomizing them to either DB-1303 (a HER2-targeted antibody-drug conjugate with a topoisomerase I inhibitor payload) or standard single-agent chemotherapy.

ClinicalTrials.gov ID: NCT06018337

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

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.

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.

HealthScout AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer (ER-positive or triple-negative) with brain metastases or any HER2-negative subtype with leptomeningeal disease, who receive datopotamab deruxtecan, an anti-TROP2 antibody-drug conjugate delivering a topoisomerase I inhibitor. All participants must have CNS involvement, good performance status, and no major comorbidities; the drug is given IV every 3 weeks.

ClinicalTrials.gov ID: NCT06176261