Your session is about to expire
← Back to Search
Monoclonal Antibodies
Immunotherapy with ABBV-927 + ABBV-181 for Cancer
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks after participant's first dose
Awards & highlights
Study Summary
This trial is testing a new drug to treat advanced solid tumors. The drug will be given alone or with another new drug to see what is the maximum tolerated dose that can be given without severe side effects.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried standard treatments without success or can't tolerate them. They must have good liver, kidney, and bone marrow function, stable heart health, and a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory. Not eligible if using immunosuppressants (with exceptions), history of severe immune-related neurotoxicity/pneumonitis from immunotherapy, uncontrolled diseases like hypertension or arrhythmia, pregnant/breastfeeding/planning to conceive soon.Check my eligibility
What is being tested?
The study tests ABBV-927 and ABBV-181 as potential cancer treatments. It's a dose-escalation study to find the safest and most effective doses when given alone or together. Participants will be monitored for how their bodies absorb these drugs (pharmacokinetics) and respond to them (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system affecting various organs due to the nature of immunotherapies like ABBV-927 and ABBV-181. Specific side effects depend on dosage levels determined during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within the required range.
Select...
My cancer has worsened despite treatment, or I cannot tolerate the treatment.
Select...
I can carry out all my usual activities without help.
Select...
My kidneys work well, with a creatinine clearance of 50 mL/min or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks after participant's first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks after participant's first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the serum concentration-time curve (AUCt) of ABBV-181
Area under the serum concentration-time curve (AUCt) of ABBV-927
Maximum observed serum concentration (Cmax) of ABBV-181
+9 moreSecondary outcome measures
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)
Duration of objective response (DOR)
Objective response rate (ORR)
+1 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Expansion Arm C: ABBV-927+ABBV-181Experimental Treatment2 Interventions
Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.
Group II: Expansion Arm B: ABBV-927+ABBV-181Experimental Treatment2 Interventions
Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.
Group III: Expansion Arm A: ABBV-927Experimental Treatment1 Intervention
Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.
Group IV: Escalating Arm 6 (Japan): ABBV-927+ABBV-181Experimental Treatment2 Interventions
Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.
Group V: Escalating Arm 5 (Japan): ABBV-927Experimental Treatment1 Intervention
Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.
Group VI: Escalating Arm 4: ABBV-927+ABBV-181Experimental Treatment2 Interventions
Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.
Group VII: Escalating Arm 3: ABBV-927+ABBV-181Experimental Treatment2 Interventions
Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.
Group VIII: Escalating Arm 2: ABBV-927Experimental Treatment1 Intervention
Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.
Group IX: Escalating Arm 1: ABBV-927Experimental Treatment1 Intervention
Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-181
2013
Completed Phase 1
~500
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,221 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,935 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within the required range.My cancer has worsened despite treatment, or I cannot tolerate the treatment.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I have never had severe nerve or lung problems from immunotherapy.I do not have an untreated cancer in my brain or spinal cord.I am in Japan and have a history of or currently have interstitial lung disease.I am not pregnant or breastfeeding and do not plan to become pregnant soon.I am a male not planning to father a child or donate sperm during and up to 5 months after the study.I can carry out all my usual activities without help.I haven't had an autoimmune disease in the last 2 years.My heart's pumping ability is confirmed to be sufficient for the study.My bone marrow, kidneys, and liver are functioning well.I have never stopped an immunotherapy due to a severe side effect.My kidneys work well, with a creatinine clearance of 50 mL/min or more.I have never had immune system disorders, organ transplants, tuberculosis, inflammatory bowel disease, or lung conditions.I do not have uncontrolled health issues like high blood pressure or heart problems.I have HNSCC or NSCLC, have had platinum therapy and PDL1 therapy, and only one immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Arm B: ABBV-927+ABBV-181
- Group 2: Expansion Arm A: ABBV-927
- Group 3: Escalating Arm 6 (Japan): ABBV-927+ABBV-181
- Group 4: Expansion Arm C: ABBV-927+ABBV-181
- Group 5: Escalating Arm 1: ABBV-927
- Group 6: Escalating Arm 2: ABBV-927
- Group 7: Escalating Arm 3: ABBV-927+ABBV-181
- Group 8: Escalating Arm 4: ABBV-927+ABBV-181
- Group 9: Escalating Arm 5 (Japan): ABBV-927
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger