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CBX-663

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

CBX-663 · 1 trial · 3 indications

Phase 1 1
NCT07779798A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.Advanced Solid Tumors
NOT YET_RECRUITING120 Analytics
PHASE1NOT YET_RECRUITING
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.
Advanced Solid Tumors
NCT07779798120
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Study Endpoints

Primary Endpoints

Recommended Phase 2 Dose (RP2D)
Until the end of study (approximately 24 months)

To determine the RP2D.

To determine safety and tolerability of CBX-663; Dose Limiting Toxicities (DLTs), Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs).
From enrollment through 30 days following end of treatment.

Frequency and type of dose-limiting toxicities (DLT), Frequency, duration, and severity of treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs), and serious adverse events (SAEs), Frequency and severity of cytokine release syndrome (CRS) adverse events (AEs), Withdrawal from the study, drug discontinuations, drug interruptions, or dose reductions due to adverse events Incidence/shifts of clinical laboratory abnormalities

To assess the PK of CBX-663: AUC0-t
Approximately 1 year.

Area under the plasma concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of CBX-663 and relevant metabolites.

To assess the PK of CBX-663: Cmax
Approximately 1 year.

Maximum plasma concentration (Cmax) of CBX-663 and relevant metabolites.

To assess the PK of CBX-663: Tmax
Approximately 1 year.

Time to observed maximum plasma concentration of CBX-663 and relevant metabolites

To assess the PK of CBX-663: Ctau
Approximately 1 year.

CBX-663 drug concentration at the end of the dosing interval.

To assess the PK of CBX-663: T½
Approximately 1 year.

Terminal elimination half-life of CBX-663.

To assess the PK of CBX-663: Degree of accumulation
Approximately 1 year.

Degree of CBX-663 accumulation in the blood stream and body.

To assess the preliminary anti-leukemic activity of CBX-663 in participants with R/R AML (Cohort A):
From enrollment through 30 days following end of treatment

Objective response rate (ORR), complete response (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi) (Dohner, 2022) CR rate (CR+CRh) CRc Rate (CR+ CRh + CRi)

To assess the preliminary anti-leukemic activity of CBX-663 in participants with R/R CMML (Cohort A)
From enrollment through 30 days following end of treatment.

Response criteria for CMML: evaluated per IWG 2015 (Savona, 2015) in adults with endpoints including CR, PR, complete cytogenetic remission, marrow response and clinical benefit as appropriate

To assess the preliminary anti-leukemic activity of CBX-663 in participants with R/R MDS (Cohort A):
From enrollment through 30 days following end of treatment.

Best Overall Response (BOR) as defined by MDS/MPN International Working Group (IWG) 2023 (Zeidan, 2023) for Higher-Risk MDS and IWG 2018 (Platzbecker, 2019) for Lower-Risk MDS

To assess the preliminary anti-leukemic activity of CBX-663 in participants in Cohort A: Duration of Response (DoR)
From enrollment through 30 days following end of treatment.

To assess the duration of response (DoR) of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in participants in Cohort A: Time to Response (TTR)
From enrollment through 30 days following end of treatment.

To assess the time to response (TTR) of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in participants with R/R AML, MDS or CMML (Cohort A): CRminimal residual disease (MRD)- rate for participants with CRc.
From enrollment through 30 days following end of treatment.

To assess the CRminimal residual disease (MRD)- rate for participants with CRc of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Hematologic Improvement (HI)
From enrollment through 30 days following end of treatment.

HI defined as: * Not meeting criteria for CR (or CR equivalent) or CRuni or CRL * HIerythroid (HI-E) * HIplatelets (HI-P) * HIneutrophils (HI-N)

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Transfusion Independence
From enrollment through 30 days following end of treatment.

Transfusion independence defined as any transfusion-free period lasting for at least 56 consecutive days, during which the participant is either on CBX-663 therapy or after cessation of CBX-663 therapy but prior to the start of new therapy.

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Transfusion burden reduction
From enrollment through 30 days following end of treatment.

To assess the transfusion burden reduction of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Rate of leukemic transformation
From enrollment through 30 days following end of treatment.

To assess the rate of leukemic transformation of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Event free survival (EFS)
From enrollment through 30 days following end of treatment.

To assess the Event free survival (EFS) of CBX-663.

To assess the preliminary anti-leukemic activity of CBX-663 in Cohort A: Overall Survival (OS)
From enrollment through 30 days following end of treatment.

To assess the Overall Survival (OS) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Overall Response Rate (ORR)
From enrollment through 30 days following the end of treatment.

To assess overall response rate (ORR) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Duration of Response (DoR)
From enrollment through 30 days following end of treatment.

To assess duration of response of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Time to Response (TTR)
From enrollment through 30 days following end of treatment.

To assess time to response (TTR) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Disease Control Rate (DCR)
From enrollment through 30 days following end of treatment.

To assess disease control rate (DCR) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Progression Free Survival (PFS)
From enrollment through 30 days following end of treatment.

To assess progression free survival (PFS) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort B based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria: Overall Survival (OS)
From enrollment through 30 days following end of treatment.

To assess overall survival (OS) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in participants with recurrent/progressive GBM (Cohort C): Overall Response Rate (ORR)
From enrollment through 30 days following the end of treatment.

To assess the overall response rate (ORR) per Response Assessment in Neuro-Oncology (RANO) Criteria 2.0 (Wen 2023) and iRANO

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Duration of Response (DoR)
From enrollment through 30 days following end of treatment.

To assess duration of response (DoR) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Time to Response (TTR)
From enrollment through 30 days following end of treatment.

To assess time to response (TTR) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Disease Control Rate (DCR)
From enrollment through 30 days following end of treatment.

To assess disease control rate of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Progression Free Survival (PFS)
From enrollment through 30 days following end of treatment.

To assess progression free survival (PFS) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Overall Survival (OS)
From enrollment through 30 days following end of treatment.

To assess overall survival (OS) of CBX-663.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Changes in Corticosteroid Use
From enrollment through 30 days following end of treatment.

To assess changes in corticosteroid use in participants with GBM.

To assess the preliminary anti-tumor activity of CBX-663 in Cohort C: Changes in neurologic function as assessed by the Neurological Assessment in Neuro-Oncology scale
From enrollment through 30 days following end of treatment.

To assess changes in neurologic function as assessed by the Neurological Assessment in Neuro-Oncology scale in participants with GBM.

Secondary Endpoints

To assess the immunogenicity of CBX-663.
From enrollment through 30 days following the end of treatment.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CBX-663EXPERIMENTALIntravenous (I.V.) CBX-663

Interventions

NameTypeDescription
CBX-663DRUGIntravenous (I.V.) CBX-663
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Cohort A (R/R AML, MDS or CMML) Specific Inclusion Criteria: 1. R/R AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy. Participants with persistent leukemia after initial therapy or with r...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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