Advanced Squamous TumorsPhase 1NCT07241039
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
A Phase 1 study testing ABBV-711 and Budigalimab in people with Advanced Squamous Tumors, run by AbbVie at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Squamous Tumors
- What is being tested?
- ABBV-711 and Budigalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 20 Nov 2025to Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
United States6 sites, 6 recruiting
- Recruiting
University of Chicago Medical Center /ID# 276638
Chicago, Illinois, 60637
- Recruiting
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California, 91030
- Recruiting
START Midwest /ID# 272505
Grand Rapids, Michigan, 49546
- Recruiting
Carolina BioOncology Institute /ID# 272380
Huntersville, North Carolina, 28078
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California, 92618
- Recruiting
Next Oncology Dallas /ID# 276659
Irving, Texas, 75039
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus- Haifa /ID# 276799
Haifa, 3109601
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, 91120
- Recruiting
The Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Tel Aviv, 5265601
Canada2 sites, 2 recruiting
- Recruiting
CHUM - Centre hospitalier de l Universite de Montreal /ID# 277586
Montreal, Quebec, H2X 0A9
- Recruiting
Princess Margaret Cancer Centre /ID# 276852
Toronto, Ontario, M5G 2M9
Japan2 sites, 2 recruiting
- Recruiting
Kansai Medical University Hospital /ID# 276586
Hirakata-shi, Osaka, 573-1191
- Recruiting
National Cancer Center Hospital East /ID# 276585
Kashiwa-shi, Chiba, 277-8577
About this study
Official title: A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors
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.
Read more
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
- Being tested
- ABBV-711, Budigalimab
- Keywords
- Advanced Squamous Tumors, ABBV-711, ABBV-181, Budigalimab, Head and Neck Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer, sqNSCLC, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-711Drug
Oral Tablet
BudigalimabDrug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-711 Monotherapy Dose Escalation | Experimental | Participants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration. Receives: Drug: ABBV-711 |
| Part 2a: ABBV-711 Monotherapy Dose Expansion | Experimental | Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration. Receives: Drug: ABBV-711 |
| Part 2b: ABBV-711 Monotherapy Dose Expansion | Experimental | Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration. Receives: Drug: ABBV-711 |
| Part 3: ABBV-711 + BudigalimabDose Escalation | Experimental | Participants will receive ABBV-711 in escalating doses in combination with budigalimab, as part of the 5 year study duration. Receives: Drug: ABBV-711; Drug: Budigalimab |
| Part 4a: ABBV-711 Budigalimab Dose Expansion | Experimental | Participants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration. Receives: Drug: ABBV-711; Drug: Budigalimab |
| Part 4b: ABBV-711 Budigalimab Dose Expansion | Experimental | Participants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration. Receives: Drug: ABBV-711; Drug: Budigalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AE)s
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.
Measured: Up to Approximately 5 Years
Best overall Response (BOR)
BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to Approximately 5 Years
Secondary outcomes (9)
Duration of BOR Response
Duration of response for participants with confirmed PR or better.
Measured: Up to Approximately 5 Years
Clinical Benefit Rate (CBR)
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.
Measured: Up to Approximately 5 Years
Progression-free survival (PFS)
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.
Measured: Up to Approximately 5 Years
Duration of response (DOR)
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.
Measured: Up to Approximately 5 Years
Overall survival (OS)
OS is defined as time from first ABBV-711 to death due to any cause.
Measured: Up to Approximately 5 Years
Area Under the Concentration-Time Curve (AUC) of ABBV-711
Area under the concentration-time curve of ABBV-711.
Measured: Up to Approximately 5 Years
Maximum Observed Concentration (Cmax) of ABBV-711
Maximum observed concentration of ABBV-711.
Measured: Up to Approximately 5 Years
Time to Cmax (Tmax) of ABBV-711
Time to Cmax of ABBV-711.
Measured: Up to Approximately 5 Years
Half-Life (t1/2) of ABBV-711
Half-life of ABBV-711.
Measured: Up to Approximately 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start20 Nov 2025
- Primary completionApr 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Squamous TumorsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241039
- Sponsor's protocol ID
- M25-632
- Other IDs
- 2025-521607-48-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors
- ClinicalTrials.gov ID
- NCT07241039
- Acronym / sponsor ID
- M25-632
- Conditions
- Advanced Squamous Tumors
- Keywords
- Advanced Squamous Tumors, ABBV-711, ABBV-181, Budigalimab, Head and Neck Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer, sqNSCLC, HNSCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-711 Monotherapy Dose Escalation | Experimental | Drug: ABBV-711Participants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration. |
| Part 2a: ABBV-711 Monotherapy Dose Expansion | Experimental | Drug: ABBV-711Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration. |
| Part 2b: ABBV-711 Monotherapy Dose Expansion | Experimental | Drug: ABBV-711Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration. |
| Part 3: ABBV-711 + BudigalimabDose Escalation | Experimental | Drug: ABBV-711, Drug: BudigalimabParticipants 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 | Experimental | Drug: ABBV-711, Drug: BudigalimabParticipants 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 | Experimental | Drug: ABBV-711, Drug: BudigalimabParticipants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-711Oral Tablet | Drug | Part 1: ABBV-711 Monotherapy Dose Escalation, Part 2a: ABBV-711 Monotherapy Dose Expansion, Part 2b: ABBV-711 Monotherapy Dose Expansion, Part 3: ABBV-711 + BudigalimabDose Escalation, Part 4a: ABBV-711 Budigalimab Dose Expansion, Part 4b: ABBV-711 Budigalimab Dose Expansion |
| BudigalimabIntravenous Infusion | Drug | Part 3: ABBV-711 + BudigalimabDose Escalation, Part 4a: ABBV-711 Budigalimab Dose Expansion, Part 4b: ABBV-711 Budigalimab Dose Expansion |
Primary outcome
Number of Participants with Adverse Events (AE)s
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Duration of BOR Response
Time frame: Up to Approximately 5 Years
Clinical Benefit Rate (CBR)
Time frame: Up to Approximately 5 Years
Progression-free survival (PFS)
Time frame: Up to Approximately 5 Years
Duration of response (DOR)
Time frame: Up to Approximately 5 Years
Overall survival (OS)
Time frame: Up to Approximately 5 Years
Area Under the Concentration-Time Curve (AUC) of ABBV-711
Time frame: Up to Approximately 5 Years
Maximum Observed Concentration (Cmax) of ABBV-711
Time frame: Up to Approximately 5 Years
Time to Cmax (Tmax) of ABBV-711
Time frame: Up to Approximately 5 Years
Half-Life (t1/2) of ABBV-711
Time frame: Up to Approximately 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-711 and Budigalimab in people with Advanced Squamous Tumors, run by AbbVie at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel, Canada, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE)s (time frame: Up to Approximately 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.