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ABL103

Phase 1

Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 8, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

ABL103 · 1 trial · 1 indication

Phase 1 1
NCT07158918ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid TumorsSolid Tumors
RECRUITING65 Analytics
PHASE1RECRUITING
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose-Limiting Toxicities (DLTs)
Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs)
From baseline through study completion, an average of 12 months
Recommended Dose for Expansion (RDE) Determination
From baseline through study completion, an average of 12 months
Objective Response Rate (ORR)
Up to approximately 30 months
Disease Control Rate (DCR)
Up to approximately 30 months

Secondary Endpoints

Preliminary Objective Response Rate (ORR)
Up to approximately 30 months
Preliminary Disease Control Rate (DCR)
Up to approximately 30 months
Incidence of Anti-Drug Antibodies (ADA)
From baseline through study completion, an average of 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABL103 (DL1) + pembrolizumabEXPERIMENTALSafety Lead-in Part 1
ABL103 (DL2-1) + pembrolizumab + taxaneEXPERIMENTALSafety Lead-in Part 2
ABL103 (DL2) + pembrolizumab + taxaneEXPERIMENTALSafety Lead-in Part 2
Group 1) ABL103 + pembrolizumab + taxaneEXPERIMENTALDose-expansion Part
Group 2) ABL103 + pembrolizumab + taxaneEXPERIMENTALDose-expansion Part

Interventions

NameTypeDescription
ABL103DRUGIV infusion
KEYTRUDA® (pembrolizumab)DRUGIV infusion
TaxaneDRUGIV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions. * Subjects must be ≥18 years of age on the day of signing the informed consent form (ICF). * Subject must have a histologically or cytologically...

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

Frequently asked questions about ABL103

What is ABL103 used for in solid tumors?

ABL103 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development, evaluated in combination with pembrolizumab, with or without a taxane, in patients with solid tumors.

Who makes ABL103?

ABL103 is being developed by Merck & Company, Inc., traded on the New York Stock Exchange under the ticker MRK. The company is conducting a Phase 1 clinical trial of ABL103 in advanced or metastatic solid tumors.

What phase is ABL103 in?

ABL103 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in a recruiting Phase 1 trial for advanced or metastatic solid tumors.

What clinical trials is ABL103 in?

ABL103 is being studied in one active clinical trial, NCT07158918, titled 'ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors.' This Phase 1 trial is recruiting 65 participants in the United States, Australia, and South Korea.

Is ABL103 being studied in a randomized controlled trial?

Yes, the Phase 1 trial of ABL103 (NCT07158918) is randomized and controlled, but it is not double-blinded. The trial is biomarker-selected and enrolls patients aged 18 years and older with solid tumors.