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ABBV-711

Phase 1

Advanced Squamous Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-711 · 1 trial · 1 indication

Phase 1 1
NCT07241039A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous TumorsAdvanced Squamous Tumors
RECRUITING220 Analytics
PHASE1RECRUITING
A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors
Advanced Squamous TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AE)s
Up to Approximately 5 Years

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Best overall Response (BOR)
Up to Approximately 5 Years

BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Endpoints

Duration of BOR Response
Up to Approximately 5 Years
Clinical Benefit Rate (CBR)
Up to Approximately 5 Years
Progression-free survival (PFS)
Up to Approximately 5 Years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: ABBV-711 Monotherapy Dose EscalationEXPERIMENTALParticipants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration.
Part 2a: ABBV-711 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive ABBV-711 dose A alone, as part of the 5 year study duration.
Part 2b: ABBV-711 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive ABBV-711 dose B alone, as part of the 5 year study duration.
Part 3: ABBV-711 + BudigalimabDose EscalationEXPERIMENTALParticipants will receive ABBV-711 in escalating doses in combination with budigalimab, as part of the 5 year study duration.
Part 4a: ABBV-711 Budigalimab Dose ExpansionEXPERIMENTALParticipants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration.
Part 4b: ABBV-711 Budigalimab Dose ExpansionEXPERIMENTALParticipants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration.

Interventions

NameTypeDescription
ABBV-711DRUGOral Tablet
BudigalimabDRUGIntravenous Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ineligible for or are intolerant to standard of care therapy are eligible). * Received programmed cell death protein 1 (PD-1)/program...

Countries:United StatesCanadaIsraelJapan
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07241039lastUpdatePostDate: changed
LOWAug 20, 2026NCT07241039lastUpdatePostDate: changed
LOWAug 20, 2026NCT07241039lastUpdatePostDate: changed
LOWAug 20, 2026NCT07241039lastUpdatePostDate: changed

Frequently asked questions about ABBV-711

What is ABBV-711 used for?

ABBV-711 is an investigational small molecule being developed for the treatment of advanced squamous tumors. It is currently in Phase 1 clinical development and is being studied as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors.

What does ABBV-711 target?

The molecular target of ABBV-711 has not been disclosed. It is a small molecule being studied for its effects on disease activity in advanced squamous tumors, but its specific mechanism of action has not been publicly detailed.

Who makes ABBV-711?

ABBV-711 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting a Phase 1 clinical trial to evaluate the drug in adults with advanced squamous tumors.

What phase is ABBV-711 in?

ABBV-711 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to assess its safety, tolerability, and pharmacokinetics.

What clinical trials is ABBV-711 in?

ABBV-711 is being evaluated in a Phase 1 trial with the identifier NCT07241039. This study assesses adverse events, change in disease activity, and how oral ABBV-711 tablets move through the body as a monotherapy and in combination with intravenously infused budigalimab (ABBV-181) in adults with advanced squamous tumors.

Is ABBV-711 the same as budigalimab?

No, ABBV-711 is not the same as budigalimab. ABBV-711 is an oral small molecule being studied as a monotherapy and in combination with budigalimab (ABBV-181), which is a separate investigational drug administered intravenously. The two agents are being evaluated together in a Phase 1 trial.