What is clinical trial NCT07241039 studying?

NCT07241039 is a Phase 1 clinical trial evaluating ABBV-711 for Advanced Squamous Tumors. The trial is sponsored by AbbVie and is currently recruiting.

What phase is the NCT07241039 clinical trial?

NCT07241039 is a Phase 1 clinical trial. Phase 3 trials are pivotal studies required before FDA approval, typically enrolling hundreds to thousands of participants to prove efficacy and safety.

Is NCT07241039 still recruiting participants?

The current enrollment status of NCT07241039 is: RECRUITING. The trial is actively enrolling — check ClinicalTrials.gov for eligibility criteria.

Who is the sponsor of clinical trial NCT07241039?

NCT07241039 is sponsored by AbbVie (ABBV). BiotechSign currently grades the sponsor a C (58/100) based on its composite pipeline strength and catalyst outlook.

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NCT07241039Phase 1RECRUITING

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

Study Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors. ABBV-711 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide. In part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent questionnaire, medical assessments, blood tests, and scans.

Conditions

Advanced Squamous Tumors

Interventions / Drugs

ABBV-711 Budigalimab

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment220 participants

Primary Completion—

Lead SponsorAbbVie

Data Retrieved2026-04-11 02:51:51.325331+00:00

What This Trial Means for Biotech Investors

Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 220 participants

Sponsor Catalyst Profile

AbbVie Inc (ABBV) is the sponsoring company for this trial. BiotechSign currently grades this company C (58/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

ABBV Full Pipeline →All Companies →

Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.