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New treatment option for Advanced Squamous Tumors
Official title 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
ClinicalTrials.gov ID: NCT07241039
What this study is testing
What is ABBV-711?
ABBV-711 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced squamous tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered...
- 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...
- For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), people must provide consent to paired biopsies...
- Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
You likely can't join if
- Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism and psoriasis (not requiring systemic treatment)...
- 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...
- 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...
- Has systemically used known moderate/strong inducers of CYP3A within 14 days prior to the first dose of study treatment.
See the full eligibility 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...
- For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), people must provide consent to paired biopsies which are pretreatment and on treatment fresh tumor biopsies from the...
- Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Chicago, Illinois, United States
- Grand Rapids, Michigan, United States
- Huntersville, North Carolina, United States
- Irving, Texas, United States
- Toronto, Ontario, Canada
- Ramat Gan, Tel Aviv, Israel
- Haifa, Israel
- Jerusalem, Israel
- Kashiwa-shi, Chiba, Japan
- Hirakata-shi, Osaka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States; Huntersville, North Carolina, United States; Irving, Texas, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.