Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

Study summary

This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCBX-12

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Cybrexa Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Cybrexa Therapeutics
Interventions being studied: Drug: CBX-12

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
Has measurable disease per RECIST 1.1.
An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
Agrees to an on-treatment biopsy preferably of the same lesion from which the pre-CBX-12 treatment sample was obtained as long as the Investigator determines such biopsy can be performed with acceptable safety. (Removed Amd 4, date 31-Mar-2023)

Reasons someone may not be able to joinExclusion criteria

Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be reduced to 2 weeks for bone only radiation therapy or investigational agents not expected to be associated with adverse events (AEs) after 2 weeks of last administration, with Medical Monitor approval.
Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days prior to the first dose of CBX-12.
Subjects who are currently receiving any other anti cancer or investigational agent(s).
Clinically significant intercurrent disease.
Subjects with primary central nervous system (CNS) tumors or clinically active CNS metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Medical Monitor approval.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Yale Cancer CenterNew Haven, Connecticut
NEXT OncologyAustin, Texas
MD Anderson Cancer CenterHouston, Texas
NEXT OncologySan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 20, 2026. Always confirm current availability with the study team.

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