Testing CBX-12 for Advanced Solid Cancers
This study, NCT05691517, is testing a drug called CBX-12 in people with advanced solid cancers that have spread or grown despite previous treatments. CBX-12 works by damaging cancer cell DNA, which can lead to cancer cell death. The study aims to see how your body responds to CBX-12 by looking at certain markers in your tumor and blood. To join, you must have solid tumors that have spread and have measurable disease. Researchers will assess how well CBX-12 affects cancer cells and if it shrinks tumors. The study also looks at the safety of CBX-12. The current status of this study is unclear, and it plans to enroll 35 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 35 participants.
- What's involved
- You would undergo a tumor biopsy, blood draws, and CT scans. You would receive CBX-12 intravenously (through a vein).
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure early responses to the drug around day 2 of the first cycle (a cycle is 28 days) and later responses around day 1 of the third cycle.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05691517
Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~35 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographypH Low Insertion Peptide-exatecan Conjugate CBX-12
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Early Rad51/deoxyribonucleic acid (DNA) damage response (DDR)
Measured over At cycle 1 day 2 (1 cycle = 28 days)
+1 more outcome measured
Conditions
NCT05691517
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alice P Chen · PRINCIPAL_INVESTIGATOR · National Cancer Institute LAO
Who to contact
Site Public Contact
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Eligibility criteria
Inclusion
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 diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam)
Patients must have a tumor site amenable to biopsy
Age \>= 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 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)
Subjects may receive supplementation to meet this eligibility criteria
Magnesium ≥ LLN
Subjects may receive supplementation to meet this eligibility criteria
Ionized/corrected calcium ≥ LLN
Subjects may receive supplementation to meet this eligibility criteria
Creatinine =\< 1.5 x institutional ULN or creatinine clearance levels \>= 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 completed within 28 days prior to enrollment
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 efficacy assessment of the investigational regimen are eligible for this trial
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 Functional Classification. To be eligible for this trial, patients should be class 2B or better
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 men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation and for at least 4 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CBX-12 and for 4 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CBX-12 administration
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
Exclusion
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 subjects 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 therapeutic index are ineligible, if they cannot be transferred to alternative medication. Patients on substrates of OATP1B1 and OATP1B3 should be excluded unless they can be transferred on alternative medication. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
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 adequate contraception (hormonal or barrier method of birth control or abstinence) for the duration of study participation and for at least 4 months after the last dose of the study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother and because it is not known if the agent can be excreted in human milk, breastfeeding should be discontinued while the mother is taking CBX-12 and for 4 months after cessation of treatment
What this trial measures
- Early Rad51/deoxyribonucleic acid (DNA) damage response (DDR)At cycle 1 day 2 (1 cycle = 28 days)
- Late Rad51/DDR responseAt cycle 3 day 1