Clinical Trials for Other Solid Tumor

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

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 newly diagnosed, untreated de novo HER2-positive metastatic breast cancer (including those with stable, treated brain metastases), testing a sequential regimen of standard HER2-targeted therapies: taxane/trastuzumab/pertuzumab, then trastuzumab deruxtecan (HER2-targeted ADC with a topoisomerase I payload), followed by T-DM1 plus tucatinib (HER2 TKI), and finally trastuzumab/pertuzumab/tucatinib, with the intent to intensify therapy upfront and then discontinue treatment.

ClinicalTrials.gov ID: NCT06439693

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

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 metastatic or inoperable locally advanced HER2 negative metaplastic breast cancer (including triple negative breast cancer with metaplastic features) who have not previously received nab-paclitaxel or PI3K/AKT/mTOR inhibitors. Treatment consists of nab-paclitaxel plus alpelisib (an oral PI3K-alpha inhibitor) and L-NMMA (a pan-inducible nitric oxide synthase [iNOS] inhibitor), aiming to target chemoresistance pathways in this aggressive subtype.

ClinicalTrials.gov ID: NCT05660083

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.

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 study enrolls female patients with triple negative, HER2+, or hormone receptor positive breast cancer and asymptomatic, measurable brain metastases, treating them with a personalized anti-HER2/HER3 dendritic cell vaccine (designed to enhance immune targeting of HER2/HER3-expressing cells) combined with the PD-1 inhibitor pembrolizumab. Eligible patients must have ECOG 0-1 and no immediate need for local brain therapy, leptomeningeal disease, or active autoimmune/infectious conditions.

ClinicalTrials.gov ID: NCT04348747

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced 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.

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 advanced or metastatic solid tumors, specifically HR+/HER2- breast cancer progressed after standard therapy or CCNE1-amplified malignancies (including ovarian, endometrial, TNBC), to receive AVZO-021, an oral selective CDK2 inhibitor targeting cell cycle dysregulation, as monotherapy or in combination with standard agents. Patients must have measurable disease, ECOG 0–1, and no prior CDK2 inhibitor exposure.

ClinicalTrials.gov ID: NCT05867251

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

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.

HealthScout AI summary: This trial enrolls adults with advanced, previously treated solid tumors (excluding melanoma and NSCLC) from various histologies, including rare subtypes and biomarker-selected groups (e.g., TMB-high, MSI-H/dMMR), who receive pembrolizumab, a PD-1 blocking antibody immunotherapy, until progression or up to 2 years. Eligible patients must have progressed on standard therapy, have ECOG 0–1, and may not have active autoimmune disease, CNS metastases, or prior anti-PD-1/PD-L1 therapy.

ClinicalTrials.gov ID: NCT02628067

Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers

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.

HealthScout AI summary: Enrolling adults with advanced solid tumors—including RAS-mutated colorectal, pancreatic, other RAS-mutant tumors, EGFR-altered or RAS-mutant glioblastoma, and ocular melanoma (with GNAQ or GNA11 mutations)—this study tests oral neratinib (an irreversible pan-HER tyrosine kinase inhibitor) combined with divalproex sodium (a histone deacetylase inhibitor) in patients who have progressed on standard therapies.

ClinicalTrials.gov ID: NCT03919292

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

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: Adults with unresectable, liver-only metastatic colorectal cancer (after 3–6 months of first-line chemotherapy, ECOG 0-1, no significant extrahepatic disease) are randomized to standard systemic chemotherapy (e.g., FOLFOX, FOLFIRI, or OX/IRI ± targeted agents) with or without hepatic arterial infusion of floxuridine, an antimetabolite delivered directly to the liver via an implanted pump.

ClinicalTrials.gov ID: NCT05863195

A Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic, Refractory CRC

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 microsatellite stable (MSS) metastatic colorectal cancer refractory to standard therapies, testing the combination of oral abemaciclib (a selective CDK4/6 inhibitor that blocks cell cycle progression) with intravenous 5-fluorouracil. Prior CDK4/6 inhibitor use and intolerance to fluoropyrimidines are exclusion criteria.

ClinicalTrials.gov ID: NCT06654037

Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

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 study enrolls adults with advanced or metastatic colorectal cancer (excluding dMMR/MSI-H) who are candidates for first-line 5-FU-based chemotherapy (FOLFIRI or FOLFOX ± biologics), testing the addition of oral hydroxytyrosol—a polyphenol with preclinical anti-inflammatory and immune modulatory effects—to standard treatment. Eligibility requires ECOG 0–1, measurable disease, and adequate organ function.

ClinicalTrials.gov ID: NCT06833866

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

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.

HealthScout AI summary: This trial enrolls adults with metastatic gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893