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ACY-241

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 26, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ACY-241 · 2 trials · 2 indications

Phase 1 2
NCT02935790Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and NivolumabMalignant Melanoma
COMPLETED1 Analytics
NCT02551185ACY 241 in Combination With Paclitaxel in Patients With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED20 Analytics
PHASE1COMPLETED
Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab
Malignant MelanomaUnlock trial analytics
PHASE1COMPLETED
ACY 241 in Combination With Paclitaxel in Patients With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Dose Limiting Toxicities defining the MTD
12 months
Dose limiting toxicities (DLTs)
12 months
Recommended phase 2 dose and schedule of ACY 241 in combination with paclitaxel on a weekly schedule.
12 months
Maximum tolerated dose (MTD), if present.
12 months

Secondary Endpoints

Percentage of Patients with ORR based on RECIST 1.1 change from baseline by CT or MRI measurements
12 months
Percentage of Patients with ORR based on irRC change from baseline by CT or MRI measurements
12 months
Maximum observed concentration (Cmax) of ACY-241 administered in combination with ipilimumab and nivolumab
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ACY-241 combo with Ipi and NivoEXPERIMENTALACY-241 in Combination with Ipilimumab and Nivolumab
ACY-241 in combination with PaclitaxelEXPERIMENTAL -

Interventions

NameTypeDescription
ACY-241DRUGtablet
nivolumabDRUGinfusion
ipilimumabDRUGinfusion
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Eligibility Criteria

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

Inclusion Criteria: 1. Patients must have signed and dated an Institutional Review Board/Independent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures t...

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

Frequently asked questions about ACY-241

What is ACY-241 used for?

ACY-241 is an investigational small molecule being studied for the treatment of advanced solid tumors and malignant melanoma. It has been evaluated in Phase 1 clinical trials, including one in combination with paclitaxel for advanced solid tumors and another with ipilimumab and nivolumab for malignant melanoma.

Who makes ACY-241?

ACY-241 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this investigational oncology drug.

What phase is ACY-241 in?

ACY-241 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in advanced solid tumors and one in malignant melanoma.

What clinical trials is ACY-241 in?

ACY-241 has been studied in two completed Phase 1 trials. NCT02551185 evaluated ACY-241 in combination with paclitaxel in patients with advanced solid tumors, enrolling 20 participants. NCT02935790 evaluated ACY-241 in combination with ipilimumab and nivolumab in malignant melanoma, enrolling 1 participant.

Is ACY-241 the same as ACY 241?

ACY-241 is also referred to as ACY 241 in clinical trial titles. Both names refer to the same investigational drug being developed by Bristol-Myers Squibb for oncology indications.