Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05691517

Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

35

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. This allows CBX-12 to kill the cancer cells by damaging their DNA, resulting in cancer cell death. This trial is being done to find out if this approach is better or worse than the usual approach for advanced cancers.

CONDITIONS

Official Title

Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 RECIST v1.1, with at least one lesion measurable by chest x-ray (>= 2 cm) or CT/MRI/clinical exam (>= 1 cm)
  • Patients must have a tumor site amenable to biopsy
  • Age >= 18 years
  • 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), except for Gilbert disease patients with bilirubin up to 3 mg/dl
  • INR or aPTT <= 1.5 x institutional ULN
  • AST/ALT <= 3 x institutional ULN (<= 5 x ULN for patients with liver involvement)
  • Potassium >= lower limit of normal (LLN), supplementation allowed
  • Magnesium >= LLN, supplementation allowed
  • Ionized/corrected calcium >= LLN, supplementation allowed
  • Creatinine <= 1.5 x institutional ULN or creatinine clearance >= 60 ml/min
  • Oxygen saturation > 90% on room air
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
  • Patients with chronic hepatitis B virus infection must have undetectable viral load on suppressive therapy
  • Patients with treated hepatitis C virus infection must be cured or have undetectable viral load if currently treated
  • Patients with treated brain metastases with no progression for >= 1 month
  • Patients with prior or concurrent malignancy not interfering with study assessment
  • Patients with cardiac function New York Heart Association Functional Classification class 2B or better
  • Women of child-bearing potential and men must agree to use contraception during and for 4 months after treatment
  • Willingness to provide biopsy samples
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Patients must have recovered from recent cancer immunotherapy adverse events to grade 1 or less (except alopecia or lymphopenia)
  • Use of medications or substances affecting CBX-12 or exatecan activity without possibility of change
  • Receiving other investigational agents
  • Taking medications that prolong QT interval or are strong CYP3A4/CYP1A2 inhibitors/inducers or sensitive CYP3A/CYP2B6 substrates unless changed
  • Use of substrates of OATP1B1 and OATP1B3 unless alternative medication possible
  • History of allergic reactions to CBX-12 or similar compounds
  • Uncontrolled illness limiting study compliance
  • Pregnant women or breastfeeding mothers
  • Women of child-bearing potential must use contraception during and 4 months after study
  • Breastfeeding should be discontinued during and 4 months after treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States, 20892

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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