BridgeMD
New treatment option for Advanced Malignant Solid Neoplasm
Official title Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers
ClinicalTrials.gov ID: NCT05691517
What this study is testing
What is pH Low Insertion Peptide-exatecan Conjugate CBX-12?
pH Low Insertion Peptide-exatecan Conjugate CBX-12 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignant solid neoplasm.
Also referred to as Alphalex Conjugate CBX-12, Alphalex-exatecan Conjugate CBX-12.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies how well CBX-12 works in treating patients with solid tumors that have spread from where they first started (primary site) to started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or other places in the body (metastatic). CBX-12 works by binding to a protein called TOP1 that is present inside the cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed solid tumors with metastatic disease that have progressed after \>= 1 line of prior therapy
- Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, with at least one lesion...
- Patients must have a tumor site amenable to biopsy
- Age \>= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%)
You likely can't join if
- Patients must have recovered from clinically-significant adverse-events of their most recent cancer immunotherapy to grade 1 or less (with the...
- Eligibility of people receiving any medications or substances with the potential to affect the activity of CBX-12 or exatecan will be determined...
- Patients who are receiving any other investigational agents
- Patients taking medication known to prolong the QT interval, or receiving any medications or substances that are strong CYP3A4 or CYP1A2 inhibitors...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBX-12 (e.g., other topoisomerase I inhibitors)...
- Patients with uncontrolled intercurrent illness that would limit compliance with study requirements
See the full eligibility criteria
- Patients must have histologically confirmed solid tumors with metastatic disease that have progressed after \>= 1 line of prior therapy
- Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, with at least one lesion that can be accurately measured in at least one dimension (longest...
- Patients must have a tumor site amenable to biopsy
- Age \>= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%)
- Absolute neutrophil count \>= 1,500/mcL
- Hemoglobin \>= 9 g/L
- Platelets \>= 100,000/mcL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
- However, patients with known Gilbert disease who have serum bilirubin level of up to 3 mg/dl may be enrolled
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\< 1.5 institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =\< 3 x institutional ULN
- AST and/or ALT =\< 5 x ULN for patients with liver involvement
- Potassium ≥ lower limit of normal (LLN)
- people may receive supplementation to meet this eligibility criteria
- Magnesium ≥ LLN
- people may receive supplementation to meet this eligibility criteria
- Ionized/corrected calcium ≥ LLN
- people may receive supplementation to meet this eligibility criteria
- Creatinine =\ = 60 ml/min based on the Cockcroft-Gault formula
- Oxygen (O2) saturation \> 90% on room air
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For these patients, an HIV viral load test must be...
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for \>= 1 month after treatment of the brain metastases
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of CBX-12 on the developing human fetus are unknown. For this reason and because biologicals conjugated to topoisomerase 1 inhibitor agents are known to be teratogenic, women of child-bearing potential and...
- Willingness to provide biopsy samples for research purposes
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
- Patients must have recovered from clinically-significant adverse-events of their most recent cancer immunotherapy to grade 1 or less (with the exception for alopecia or lymphopenia)
- Eligibility of people receiving any medications or substances with the potential to affect the activity of CBX-12 or exatecan will be determined following review of their cases by the Principal Investigator
- Patients who are receiving any other investigational agents
- Patients taking medication known to prolong the QT interval, or receiving any medications or substances that are strong CYP3A4 or CYP1A2 inhibitors or inducers, and sensitive substrates of CYP3A or CYP2B6 with a narrow...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBX-12 (e.g., other topoisomerase I inhibitors) or the inactive ingredients in the drug product
- Patients with uncontrolled intercurrent illness that would limit compliance with study requirements
- Pregnant women are excluded from this study because CBX-12 is an investigational agent with unknown potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential must agree to use...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.