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CB-5339

Phase 1

Acute Myeloid Leukemia, in Relapse | Small molecule | Oncology |Eikon Therapeutics, Inc.|Last Updated: Aug 31, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

CB-5339 · 1 trial · 2 indications

Phase 1 1
NCT04402541Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic SyndromeAcute Myeloid Leukemia, in Relapse
COMPLETED55 Analytics
PHASE1COMPLETED
Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute Myeloid Leukemia, in RelapseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
28 Days
Define the MTD and/or RP2D and schedule for CB-5339
28 Days

Incidence and nature of DLTs with CB-5339 monotherapy for MTD determination. All available safety, efficacy and PK, for RP2D determination

Secondary Endpoints

Peak plasma concentration (Cmax)
Day 1 and Day 4
Time to reach peak plasma concentration (Tmax)
Day 1 and Day 4
Area under the plasma concentration time curve (AUC0-t)
Day 1 and Day 4
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CB-5339EXPERIMENTALOrally administered CB-5339

Interventions

NameTypeDescription
CB-5339DRUG25mg and 75mg capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Male or female and ≥ 18 years of age at the time of signing the consent form 2. One of the following advanced hematologic malignancies including: * Relapsed or refractory AML as defined by 2016 WHO criteria and are not candidates for curative therapies such as allogeneic ...

Countries:United StatesAustralia
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Frequently asked questions about CB-5339

What is CB-5339 used for?

CB-5339 is an investigational small molecule being studied for the treatment of acute myeloid leukemia in relapse and myelodysplastic syndromes. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes CB-5339?

CB-5339 is being developed by Eikon Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with certain blood cancers.

What phase is CB-5339 in?

CB-5339 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still being studied in clinical trials to assess its safety and potential effectiveness.

What clinical trials is CB-5339 in?

CB-5339 has been studied in a Phase 1 clinical trial with the identifier NCT04402541, titled 'Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome.' This trial has been completed and enrolled 55 participants in the United States and Australia.

Is CB-5339 the same as any other drug?

CB-5339 is a distinct investigational compound developed by Eikon Therapeutics. It is not known to be the same as any other marketed drug, and no alternative names have been reported for this asset.