Trying oral ABBV-711 alone and with budigalimab for advanced squamous tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional study gives escalating oral doses of ABBV-711 either as a monotherapy or combined with intravenous budigalimab to adults with advanced squamous tumors. Part 1 uses dose escalation to identify tolerated ABBV-711 doses, and later parts treat participants at a selected dose in cohorts such as squamous NSCLC and head and neck squamous cell carcinoma. Approximately 220 participants at roughly 40 global sites will be enrolled, with investigators tracking safety, tolerability, pharmacokinetics and early signs of tumor response. Selected cohorts, particularly HNSCC backfill groups, require paired pre- and on-treatment biopsies to study biological effects.

Why it matters

Who can join: the full rules

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)/programmed cell death ligand 1 (PD-L1) targeted agents are eligible.
* Confirmation of available archival tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] block or freshly cut slides) or provision of fresh tissue biopsy is required for enrollment in this study for gene expression assessment. If archival tissue requirements cannot be met then the AbbVie therapeutic area Medical Director or designee should be contacted to determine subject eligibility.
* For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), subjects must provide consent to paired biopsies which are pretreatment and on treatment fresh tumor biopsies from the same tumor lesion, unless deemed not feasible by the investigator where upon consultation with the Sponsor is required. Paired biopsies are encouraged (when safe and feasible) but not required for subjects with squamous non-small cell lung cancer (sqNSCLC) enrolled in the backfill (Part 1 and 3).
* Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Exclusion Criteria:

* Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism and psoriasis (not requiring systemic treatment); history of primary immunodeficiency, bone marrow transplantation, or solid organ transplantation. Active inflammatory bowel disease unfit for trial in the opinion of the investigator, including subjects requiring systemic therapy with biologics or immunosuppressive therapy within the past 2 years.
* Treatment with any of the following:

  * Anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-711. Palliative radiation therapy for bone, skin or symptomatic metastases with 10 fractions or less is not subject to a washout period.
  * Radiation therapy for central nervous system metastases within 14 days prior to first dose.
* Subject has systemically used known moderate/strong inhibitors of cytochrome P450 3A (CYP)3A enzyme isoform subfamily within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study treatment.
* Has systemically used known moderate/strong inducers of CYP3A within 14 days prior to the first dose of study treatment.
* Requires treatment with known moderate or strong inhibitors or inducers of CYP3A from the first dose of study treatment and for the duration of the study.
* Administration or consumption of any of the following within 3 days prior to first dose of study treatment and while on study treatment: grapefruit or grapefruit products, Seville oranges (including marmaladecontaining Seville oranges), and star fruit.
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study treatment. The following are exceptions to this criterion:

  * Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);
  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
  * Systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent.

Where it's running

• City Of Hope Comprehensive Cancer Center /ID# 276550
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
  Irvine, California, United States Recruiting
• University of Chicago Medical Center /ID# 276638
  Chicago, Illinois, United States Recruiting
• START Midwest /ID# 272505
  Grand Rapids, Michigan, United States Recruiting
• Carolina BioOncology Institute /ID# 272380
  Huntersville, North Carolina, United States Recruiting
• Next Oncology Dallas /ID# 276659
  Irving, Texas, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.