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AO-176

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 22, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

AO-176 · 1 trial · 1 indication

Phase 1 1
NCT03834948AO-176 in Multiple Solid Tumor MalignanciesSolid Tumor
COMPLETED57 Analytics
PHASE1COMPLETED
AO-176 in Multiple Solid Tumor Malignancies
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of AO-176 assessed by adverse events and laboratory abnormalities
Up to 12 months

Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.

Safety of AO-176 and paclitaxel assessed by adverse events and laboratory abnormalities
Up to 12 months

Evaluate the safety of AO-176 in combination with paclitaxel measured by the number adverse events, serious adverse events and lab abnormalities.

Safety of AO-176 and pembrolizumab assessed by adverse events and laboratory abnormalities
Up to 12 months

Evaluate the safety of AO-176 in combination with pembrolizumab measured by the number adverse events, serious adverse events and lab abnormalities.

Secondary Endpoints

AO-176 anti-tumor activity assessed by changes in response criteria
Up to 12 months
AO-176 + paclitaxel anti-tumor activity assessed by changes in response criteria
Up to 12 months
AO-176 + pembrolizumab anti-tumor activity assessed by changes in response criteria
Up to 12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AO-176 Dose EscalationEXPERIMENTALEach dose escalation cohort will initially recruit 3 patients to receive AO-176 in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
AO-176 Dose ExpansionEXPERIMENTALOnce the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176.
AO-176 + Paclitaxel Dose EscalationEXPERIMENTALEach dose escalation cohort will initially recruit 3 patients to receive AO-176 and paclitaxel in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
AO-176 + Paclitaxel Dose ExpansionEXPERIMENTALOnce the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 + paclitaxel.
AO-176 + Pembrolizumab Dose EscalationEXPERIMENTALEach dose escalation cohort will initially recruit 3 patients to receive AO-176 and pembrolizumab in a standard 3+3 design; cohorts will be expanded in the event of a DLT.
AO-176 + Pembrolizumab Dose ExpansionEXPERIMENTALOnce the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 + pembrolizumab.

Interventions

NameTypeDescription
AO-176DRUGHumanized monoclonal antibody (mAb) targeting CD47
AO-176 + PaclitaxelDRUGHumanized monoclonal antibody (mAb) targeting CD47 and paclitaxel
AO-176 + PembrolizumabDRUGHumanized monoclonal antibody (mAb) targeting CD47 and pembrolizumab
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Eligibility Criteria

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

Key Inclusion Criteria 1. Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective Part A: * Epithelial ovarian carcinoma (EOC) * Endometrial carcinoma * Castration resistant prostate cancer * Non-small cell ...

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

Frequently asked questions about AO-176

What is AO-176 used for?

AO-176 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for this oncology indication. The drug is not approved and remains under clinical investigation.

Who is developing AO-176?

AO-176 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational oncology drug for solid tumors.

What phase is AO-176 in?

AO-176 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.

What clinical trials is AO-176 in?

AO-176 has one completed Phase 1 clinical trial, identified as NCT03834948, titled "AO-176 in Multiple Solid Tumor Malignancies." The study enrolled 57 participants in the United States and included patients aged 18 years and older.

Is AO-176 the same as any other drug?

AO-176 is a distinct investigational small molecule. No alternative names for this drug have been established in clinical research records.