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
- Interventions
- Drug: ABBV-711
- Registration Number
- NCT07241039
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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.
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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.
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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.
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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.
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Has systemically used known moderate/strong inducers of CYP3A within 14 days prior to the first dose of study treatment.
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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.
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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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: ABBV-711 Monotherapy Dose Escalation ABBV-711 Participants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration. Part 2a: ABBV-711 Monotherapy Dose Expansion ABBV-711 Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration. Part 2b: ABBV-711 Monotherapy Dose Expansion ABBV-711 Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration. Part 3: ABBV-711 + BudigalimabDose Escalation ABBV-711 Participants will receive ABBV-711 in escalating doses in combination with budigalimab, as part of the 5 year study duration. Part 3: ABBV-711 + BudigalimabDose Escalation Budigalimab Participants 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 Expansion ABBV-711 Participants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration. Part 4a: ABBV-711 Budigalimab Dose Expansion Budigalimab Participants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration. Part 4b: ABBV-711 Budigalimab Dose Expansion ABBV-711 Participants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration. Part 4b: ABBV-711 Budigalimab Dose Expansion Budigalimab Participants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Duration of BOR Response Up to Approximately 5 Years Duration of response for participants with confirmed PR or better.
Clinical Benefit Rate (CBR) Up to Approximately 5 Years CBR is defined as the percentage of participants with BOR of stable disease (SD) or BOR of PR or better per investigator review according to RECIST version 1.1 criteria.
Progression-free survival (PFS) Up to Approximately 5 Years PFS is defined as time from first ABBV-711 to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Duration of response (DOR) Up to Approximately 5 Years DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 or other criteria to disease progression or death of any cause, whichever occurs earlier.
Overall survival (OS) Up to Approximately 5 Years OS is defined as time from first ABBV-711 to death due to any cause.
Area Under the Concentration-Time Curve (AUC) of ABBV-711 Up to Approximately 5 Years Area under the concentration-time curve of ABBV-711.
Maximum Observed Concentration (Cmax) of ABBV-711 Up to Approximately 5 Years Maximum observed concentration of ABBV-711.
Time to Cmax (Tmax) of ABBV-711 Up to Approximately 5 Years Time to Cmax of ABBV-711.
Half-Life (t1/2) of ABBV-711 Up to Approximately 5 Years Half-life of ABBV-711.