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CBX-12

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 20, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

CBX-12 · 1 trial · 12 indications

Phase 1 1
NCT04902872Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid TumorsSolid Tumor, Adult
COMPLETED69 Analytics
PHASE1COMPLETED
Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Through the end of study, estimated as 6 months

NCI CTCAE v5.0

Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B)
15 months

Safety Review Committee Analysis of Safety and PK Data

Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12 (Schedule C)
15 months

Safety Review Committee Analysis of Safety and PK Data

Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B)
15 months

Safety Review Committee Analysis of Safety and PK Data

Phase 2: Overall response rate (ORR)
Through the end of study, estimated as 6 months

ORR Based on RECIST v1.1

Secondary Endpoints

Maximum concentration of CBX-12
5 days
Area under the curve from 0-24 hours of CBX-12
5 days
Time to maximum concentration of CBX-12
5 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Schedule B Dose Escalation (Daily Dosing x 3)EXPERIMENTALCBX-12 administered on a daily x 3, 3 week schedule
Phase 1 Schedule C Dose Escalation (Once Weekly Dosing )EXPERIMENTALCBX-12 administered once weekly, 4 week schedule
Phase 2 Ovarian Cancer Expansion CohortEXPERIMENTALCBX-12 administered TBD
Phase 2 Metastatic Breast Expansion CohortEXPERIMENTALCBX-12 administered TBD
Phase 1 Schedule A Dose Escalation (Daily Dosing x 5)EXPERIMENTALCBX-12 administered on a daily x 5, 3 week schedule
Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks)EXPERIMENTALCBX-12 administered once every 3 weeks

Interventions

NameTypeDescription
CBX-12DRUGCBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * 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. Subj...

Countries:United States
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