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AB0024

Phase 1

Neoplasms | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: May 3, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

AB0024 · 1 trial · 1 indication

Phase 1 1
NCT01323933First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid TumorsNeoplasms
COMPLETED32 Analytics
PHASE1COMPLETED
First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.
Day 71

Secondary Endpoints

To measure the tumor response by modified Response Evaluation Criteria in Solid Tumors (RECIST) and to evaluate the formation of anti-AB0024 antibodies.
Day 71
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AB0024EXPERIMENTALThe starting dose for Part A will be 1 mg/kg. Subsequent doses of 3, 10, and 20 mg/kg are planned. Three to 6 patients will be enrolled using a 3 + 3 design. Doses of AB0024 will be administered on Days 1, 15, 29, and 43 to characterize the safety, tolerability, and PK. The dose expansion phase of the study will begin upon completion of the dose escalation phase. Up to 20 patients will be enrolled into one or two cohorts of Part B. The first expansion cohort will be dosed up to the MTD defined as the highest dose level with an observed incidence of DLT in \<33% of patients enrolled from Part A.

Interventions

NameTypeDescription
AB0024DRUGComparison of different dosages of drug
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available * Measurable or evaluable disease * ECOG Performance Status of ≤2 * No known active central nervous system (CNS) tumo...

Countries:United States
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Frequently asked questions about AB0024

What is AB0024 used for?

AB0024 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed by Gilead Sciences, Inc. for use in oncology, specifically in adults with advanced solid tumors.

Who makes AB0024?

AB0024 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the safety and tolerability of this investigational small molecule in patients with advanced solid tumors.

What phase is AB0024 in?

AB0024 is in Phase 1 clinical development. It has completed a first-in-human study that evaluated its safety and tolerability in adults with advanced solid tumors. As an investigational drug, it is not yet approved by regulatory authorities and remains in clinical development.

What clinical trials is AB0024 in?

AB0024 has been studied in one clinical trial, identified as NCT01323933, titled 'First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors.' This Phase 1 study was completed in the United States and enrolled 32 participants with neoplasms.

Is AB0024 FDA approved?

AB0024 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency. Its safety and efficacy have not been established for any indication.