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IOS-1002

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 26, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

IOS-1002 · 1 trial · 1 indication

Phase 1 1
NCT05763004A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid TumorsSolid Tumor, Adult
COMPLETED47 Analytics
PHASE1COMPLETED
A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors
Solid Tumor, Adult
NCT0576300447
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Study Endpoints

Primary Endpoints

To determine the incidence of treatment emergent Adverse Events (Safety and Tolerability) of various doses of IOS-1002 administered alone and/or in combination with a PD-1 mAb in subjects with advanced solid tumors
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months

Incidence of any Adverse Event DLTs AEs leading to study treatment discontinuationAEs leading to study discontinuation Abnormal laboratory parameters, vital signs, ECOG performance status, ECG results, and physical examination

Secondary Endpoints

To investigate the preliminary antitumor activity of IOS-1002 and in combination with a PD-1 mAb
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
To characterize the PK of IOS-1002 alone and in combination with a PD-1 mAb
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
To characterize the immunogenicity of IOS-1002 alone and in combination with a PD-1 mAb
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IOS-1002 MonotherapyEXPERIMENTAL -
IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab)EXPERIMENTAL -

Interventions

NameTypeDescription
IOS-1002DRUGmonotherapy
IOS-1002 + KEYTRUDA® (pembrolizumab)DRUGcombination therapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Age ≥18 years old at the time of Screening (signing the informed consent form \[ICF\]). 2. Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1: 1. Malignancy that has relapsed or is refrac...

Countries:Australia
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Recent Changes (Last 90 Days)

MEDIUMJul 27, 2026NCT05763004TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT05763004TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT05763004TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT05763004TRIAL_REMOVED: changed

Frequently asked questions about IOS-1002

What is IOS-1002 used for?

IOS-1002 is an investigational small molecule being developed for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.

Who makes IOS-1002?

IOS-1002 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of solid tumors in adults.

What phase is IOS-1002 in?

IOS-1002 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied for the treatment of solid tumors in adults.

What clinical trials is IOS-1002 in?

IOS-1002 has been studied in one clinical trial, identified as NCT05763004. This Phase 1 trial evaluated the safety, tolerability, and efficacy of IOS-1002 administered alone and in combination with pembrolizumab, a PD-1 monoclonal antibody, in advanced solid tumors. The trial was completed in Australia.

Is IOS-1002 the same as pembrolizumab?

No, IOS-1002 is not the same as pembrolizumab. IOS-1002 is a small molecule being developed by Merck & Company, Inc., while pembrolizumab is a PD-1 monoclonal antibody. In the clinical trial NCT05763004, IOS-1002 was studied both alone and in combination with pembrolizumab.