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

Conditions

• Advanced Squamous Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ABBV-711 — DRUG
  Oral Tablet
• Budigalimab — DRUG
  Intravenous Infusion

Study Details

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.

Key Dates

Start date

Nov 20, 2025

Status verified

May 2026

Primary completion

Apr 30, 2029

Completion

Oct 31, 2030

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 5 Years ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (6)

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