Advanced Solid Tumors CancerPhase 1NCT02988960
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors
A Phase 1 study testing ABBV-927 and ABBV-181 in people with Advanced Solid Tumors Cancer, run by AbbVie at 22 sites in 7 countries.
Trial summary
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Cancer
- What is being tested?
- ABBV-927 and ABBV-181
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 22 Feb 2017to Sep 2026
- 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
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Participants have adequate bone marrow, kidney and liver function.
- Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.
- Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
- Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.
- Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
- Participants in all combination therapy arms must have recurrent or metastatic HNSCC or NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy.
- The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.
Who cannot join
- Participant must not have an active or prior documented autoimmune disease in the last 2 years.
- Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
- Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis.
- Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.
- Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.
- Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
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- Participant must not have a known uncontrolled malignancy of the central nervous system.
- Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.
- Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
- Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
- Participant is judged by the investigator to have evidence of hemolysis.
- For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States7 sites
Massachusetts General Hospital /ID# 155267
Boston, Massachusetts, 02114
The University of Chicago Medical Center /ID# 155264
Chicago, Illinois, 60637-1443
Virginia Cancer Specialists - Fairfax /ID# 155266
Fairfax, Virginia, 22031
University of Texas MD Anderson Cancer Center /ID# 155263
Houston, Texas, 77030
Carolina BioOncology Institute /ID# 155265
Huntersville, North Carolina, 28078
The Angeles Clinic and Researc /ID# 156324
Los Angeles, California, 90025
Tennessee Oncology-Nashville Centennial /ID# 158654
Nashville, Tennessee, 37203-1632
France4 sites
Institut Bergonie /ID# 162665
Bordeaux, Gironde, 33000
Centre Leon Berard /ID# 162663
Lyon, Rhone, 69373
Duplicate_Institut Regional du Cancer /ID# 163609
Montpellier, Herault, 34298
Institut Gustave Roussy /ID# 162666
Villejuif, Val-de-Marne, 94805
Spain4 sites
Hospital Universitario Fundacion Jimenez Diaz /ID# 200128
Madrid, 28040
Hospital Universitario HM Sanchinarro /ID# 200127
Madrid, 28050
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129
Majadahonda, Madrid, 28222
Hospital Universitario y Politecnico La Fe /ID# 200975
Valencia, 46026
Australia2 sites
Peninsula Oncology Centre /ID# 164372
Frankston, Victoria, 3199
Austin Health /ID# 171189
Heidelberg, Victoria, 3084
Japan2 sites
National Cancer Center Hospital /ID# 217758
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East /ID# 216870
Kashiwa-shi, Chiba, 277-8577
South Korea2 sites
Seoul National University Hospital /ID# 166291
Seoul, Seoul Teugbyeolsi, 03080
Yonsei University Health System Severance Hospital /ID# 166292
Seoul, 03722
Canada1 site
University Health Network_Princess Margaret Cancer Centre /ID# 200819
Toronto, Ontario, M5G 2M9
About this study
Official title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors Cancer
- Being tested
- ABBV-927, ABBV-181
- Keywords
- Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Advanced solid tumor, Cancer, Pancreatic adenocarcinoma, Cutaneous melanoma, ABBV-927, ABBV-181, Budigalimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-927Drug
Intravenous
ABBV-927Drug
Intratumoral
ABBV-181Drug
Also called Budigalimab
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Escalating Arm 1: ABBV-927 | Experimental | Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. Receives: Drug: ABBV-927 |
| Escalating Arm 2: ABBV-927 | Experimental | Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927. Receives: Drug: ABBV-927 |
| Escalating Arm 3: ABBV-927+ABBV-181 | Experimental | Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. Receives: Drug: ABBV-927; Drug: ABBV-181 |
| Escalating Arm 4: ABBV-927+ABBV-181 | Experimental | Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181. Receives: Drug: ABBV-927; Drug: ABBV-181 |
| Escalating Arm 5 (Japan): ABBV-927 | Experimental | Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. Receives: Drug: ABBV-927 |
| Escalating Arm 6 (Japan): ABBV-927+ABBV-181 | Experimental | Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. Receives: Drug: ABBV-927; Drug: ABBV-181 |
| Expansion Arm A: ABBV-927 | Experimental | Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927. Receives: Drug: ABBV-927 |
| Expansion Arm B: ABBV-927+ABBV-181 | Experimental | Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181. Receives: Drug: ABBV-927; Drug: ABBV-181 |
| Expansion Arm C: ABBV-927+ABBV-181 | Experimental | Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181. Receives: Drug: ABBV-927; Drug: ABBV-181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
Measured: Up to 8 weeks
Time to Cmax (Tmax) of ABBV-927
Time to Cmax (Tmax) of ABBV-927.
Measured: Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-927
Maximum observed serum concentration (Cmax) of ABBV-927.
Measured: Up to 12 weeks after participant's first dose
Terminal-Phase Elimination Rate Constant (β) of ABBV-927
Terminal-phase elimination rate constant (β)of ABBV-927.
Measured: Up to 12 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-927
Terminal half-life (t1/2) of ABBV-927.
Measured: Up to 4 weeks after participant's first dose
Area under the serum concentration-time curve (AUCt) of ABBV-927
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.
Measured: Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181
Time to Cmax (Tmax) of ABBV-181.
Measured: Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-181
Maximum observed serum concentration (Cmax) of ABBV-181.
Measured: Up to 12 weeks after participant's first dose
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal-phase elimination rate constant (β)of ABBV-181.
Measured: Up to 12 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-181
Terminal half-life (t1/2) of ABBV-181.
Measured: Up to 4 weeks after participant's first dose
Area under the serum concentration-time curve (AUCt) of ABBV-181
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.
Measured: Up to 12 weeks after participant's first dose
Number of Participants with Adverse Events
An adverse event (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 30 days after and up to 24-month of treatment period
Secondary outcomes (4)
Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
Measured: Up to 30 days after and up to 24-month of treatment period
Duration of objective response (DOR)
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measured: Up to 30 days after and up to 24-month of treatment period
Objective response rate (ORR)
ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment.
Measured: Up to 30 days after and up to 24-month of treatment period
Progression-free survival (PFS)
PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.
Measured: Up to 30 days after and up to 24-month of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start22 Feb 2017
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
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
- NCT02988960
- Sponsor's protocol ID
- M15-862
- Other IDs
- 2016-002219-16, 2016
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2016
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02988960
- Acronym / sponsor ID
- M15-862
- Conditions
- Advanced Solid Tumors Cancer
- Keywords
- Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Advanced solid tumor, Cancer, Pancreatic adenocarcinoma, Cutaneous melanoma, ABBV-927, ABBV-181
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- 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.
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Escalating Arm 1: ABBV-927 | Experimental | Drug: ABBV-927Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. |
| Escalating Arm 2: ABBV-927 | Experimental | Drug: ABBV-927Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927. |
| Escalating Arm 3: ABBV-927+ABBV-181 | Experimental | Drug: ABBV-927, Drug: ABBV-181Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. |
| Escalating Arm 4: ABBV-927+ABBV-181 | Experimental | Drug: ABBV-927, Drug: ABBV-181Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181. |
| Escalating Arm 5 (Japan): ABBV-927 | Experimental | Drug: ABBV-927Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. |
| Escalating Arm 6 (Japan): ABBV-927+ABBV-181 | Experimental | Drug: ABBV-927, Drug: ABBV-181Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. |
| Expansion Arm A: ABBV-927 | Experimental | Drug: ABBV-927Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927. |
| Expansion Arm B: ABBV-927+ABBV-181 | Experimental | Drug: ABBV-927, Drug: ABBV-181Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181. |
| Expansion Arm C: ABBV-927+ABBV-181 | Experimental | Drug: ABBV-927, Drug: ABBV-181Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Participants have adequate bone marrow, kidney and liver function.
- Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.
- Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
- Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.
Key exclusion criteria (12 listed)
- Participant must not have an active or prior documented autoimmune disease in the last 2 years.
- Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
- Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis.
- Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.
- Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.
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-927Intravenous | Drug | Escalating Arm 1: ABBV-927, Escalating Arm 3: ABBV-927+ABBV-181, Escalating Arm 5 (Japan): ABBV-927, Escalating Arm 6 (Japan): ABBV-927+ABBV-181, Expansion Arm A: ABBV-927, Expansion Arm C: ABBV-927+ABBV-181 |
| ABBV-927Intratumoral | Drug | Escalating Arm 2: ABBV-927, Escalating Arm 4: ABBV-927+ABBV-181, Expansion Arm B: ABBV-927+ABBV-181 |
| ABBV-181Also: BudigalimabIntravenous | Drug | Escalating Arm 3: ABBV-927+ABBV-181, Escalating Arm 4: ABBV-927+ABBV-181, Escalating Arm 6 (Japan): ABBV-927+ABBV-181, Expansion Arm B: ABBV-927+ABBV-181, Expansion Arm C: ABBV-927+ABBV-181 |
Primary outcome
Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
Time frame: Up to 8 weeks
The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
Time to Cmax (Tmax) of ABBV-927
Time frame: Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-927.
Maximum observed serum concentration (Cmax) of ABBV-927
Time frame: Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-927.
Terminal-Phase Elimination Rate Constant (β) of ABBV-927
Time frame: Up to 12 weeks after participant's first dose
Terminal-phase elimination rate constant (β)of ABBV-927.
Terminal half-life (t1/2) of ABBV-927
Time frame: Up to 4 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-927.
Area under the serum concentration-time curve (AUCt) of ABBV-927
Time frame: Up to 12 weeks after participant's first dose
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.
Time to Cmax (Tmax) of ABBV-181
Time frame: Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181.
Maximum observed serum concentration (Cmax) of ABBV-181
Time frame: Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-181.
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Time frame: Up to 12 weeks after participant's first dose
Terminal-phase elimination rate constant (β)of ABBV-181.
Terminal half-life (t1/2) of ABBV-181
Time frame: Up to 4 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-181.
Area under the serum concentration-time curve (AUCt) of ABBV-181
Time frame: Up to 12 weeks after participant's first dose
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.
Number of Participants with Adverse Events
Time frame: Up to 30 days after and up to 24-month of treatment period
An adverse event (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.
4 secondary outcomes
Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
Time frame: Up to 30 days after and up to 24-month of treatment period
Duration of objective response (DOR)
Time frame: Up to 30 days after and up to 24-month of treatment period
Objective response rate (ORR)
Time frame: Up to 30 days after and up to 24-month of treatment period
Progression-free survival (PFS)
Time frame: Up to 30 days after and up to 24-month of treatment period
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 9 Jan 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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-927 and ABBV-181 in people with Advanced Solid Tumors Cancer, run by AbbVie at 22 sites in 7 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 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Spain, Australia, Japan and 2 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 (time frame: Up to 8 weeks). The study lists 12 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 9 Jan 2026.