Clinical Trials for Other Solid Tumor

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

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 adults with metastatic or recurrent triple-negative breast cancer who are PD-L1 negative or have progressed after immune checkpoint inhibitor therapy (excluding those with known BRCA mutations), treating them with the PARP inhibitor niraparib, the PD-1 inhibitor dostarlimab, and localized radiation. Suitable patients must have had no more than two prior systemic therapies for metastatic disease and require radiation for palliation or local control.

ClinicalTrials.gov ID: NCT04837209

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

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 adults with metastatic or refractory/recurrent KK-LC-1 positive epithelial cancers (including gastric, breast, cervical, lung, and others) who are also HLA-A*01:01 positive and have adequate organ function. Patients receive lymphodepleting chemotherapy followed by a single infusion of autologous T cells genetically engineered to express a TCR targeting the cancer germline antigen KK-LC-1, along with high-dose aldesleukin to support T cell activity.

ClinicalTrials.gov ID: NCT05035407

Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 metastatic triple negative breast cancer (ER/PR <10%, HER2 negative) who have progressed after at least two prior systemic therapies, and evaluates intravenous ProAgio—a pegylated peptide cytotoxin targeting αvβ3 integrin on tumor stroma—combined with gemcitabine. Prior gemcitabine for metastatic disease is excluded.

ClinicalTrials.gov ID: NCT06460298

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 unresectable, locally advanced, or metastatic solid tumors who have exhausted standard therapies, good performance status (ECOG 0-1), and adequate organ function. The investigational agent is AGX101, a TM4SF1-targeted antibody-drug conjugate delivering a maytansinoid payload to tumor and tumor vasculature cells.

ClinicalTrials.gov ID: NCT06440005

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 or huMNC2-CAR22, Specific for a Cleaved Form of MUC1 (MUC1*)

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 adults with metastatic breast cancer whose tumors express MUC1* (≥30% of cells), who have progressed on standard therapies, to receive autologous CAR T cell therapy (huMNC2-CAR44 or huMNC2-CAR22) targeting the cleaved MUC1* isoform. Cohorts include hormone receptor positive/HER2 negative, HER2-positive, and triple negative subtypes.

ClinicalTrials.gov ID: NCT04020575

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

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 adults with metastatic or locally advanced, unresectable triple-negative breast cancer (TNBC) or recurrent, unresectable serous ovarian cancer who have not previously received CDK4/6 or HDAC inhibitors, and tests the combination of ribociclib (a CDK4/6 inhibitor) with belinostat (a pan-HDAC inhibitor). Dose escalation includes both TNBC and ovarian cancer patients, while dose expansion is limited to TNBC.

ClinicalTrials.gov ID: NCT04315233

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer Brain Metastases

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 adults with triple negative or BRCA-mutated, HER2-negative breast cancer with new brain metastases suitable for stereotactic radiosurgery, and tests the combination of SRS with olaparib (PARP inhibitor) followed by durvalumab (PD-L1 inhibitor) plus physician’s choice single-agent systemic therapy. Patients with prior whole brain radiotherapy, diffuse leptomeningeal disease, or previous combined PARP and immune checkpoint inhibitor therapy are excluded.

ClinicalTrials.gov ID: NCT04711824

A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with advanced unresectable or metastatic solid tumors (including a broad range such as ovarian, pancreatic, GI, lung, and more) or relapsed/refractory multiple myeloma who have failed or are intolerant to standard therapies are eligible to receive QXL138AM, a masked anti-CD138 immunocytokine fused to interferon alpha-2a designed for tumor-targeted immune activation.

ClinicalTrials.gov ID: NCT06582017

A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, particularly breast cancer and CCNE1-amplified tumors, who are refractory to or intolerant of standard therapies, to receive NKT5097, a novel oral degrader targeting CDK2 and CDK4 for inhibition of cell cycle progression. All participants must have measurable or evaluable disease, ECOG 0-1, adequate organ function, and no active CNS metastases.

ClinicalTrials.gov ID: NCT07029399

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell lung cancer, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer that has progressed after standard therapies; participants must have measurable disease, adequate organ function, and be willing to undergo tumor biopsy. Patients will receive intravenous SLV-154 (mechanism and target undisclosed) in 3-week cycles at escalating doses to determine safety and dosing parameters.

ClinicalTrials.gov ID: NCT06771219