A Study Of ABBV-927 And ABBV-181, An Immunotherapy, In Participants With Advanced Solid Tumors

Study Overview

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants 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.

N/A

Advanced Solid Tumors Cancer

DRUG: ABBV-927
DRUG: ABBV-927
DRUG: ABBV-181

M15-862
2016-002219-16 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-12-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-16
First Submitted that Met QC Criteria 2016-12-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-17
First Posted (ACTUAL) 2016-12-12	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Escalating Arm 1: ABBV-927 Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.	DRUG: ABBV-927 Intravenous
EXPERIMENTAL: Escalating Arm 2: ABBV-927 Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.	DRUG: ABBV-927 Intratumoral
EXPERIMENTAL: Escalating Arm 3: ABBV-927+ABBV-181 Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.	DRUG: ABBV-927 Intravenous DRUG: ABBV-181 Intravenous
EXPERIMENTAL: Escalating Arm 4: ABBV-927+ABBV-181 Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.	DRUG: ABBV-927 Intratumoral DRUG: ABBV-181 Intravenous
EXPERIMENTAL: Escalating Arm 5 (Japan): ABBV-927 Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.	DRUG: ABBV-927 Intravenous
EXPERIMENTAL: Escalating Arm 6 (Japan): ABBV-927+ABBV-181 Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.	DRUG: ABBV-927 Intravenous DRUG: ABBV-181 Intravenous
EXPERIMENTAL: Expansion Arm A: ABBV-927 Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.	DRUG: ABBV-927 Intravenous
EXPERIMENTAL: Expansion Arm B: ABBV-927+ABBV-181 Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.	DRUG: ABBV-927 Intratumoral DRUG: ABBV-181 Intravenous
EXPERIMENTAL: Expansion Arm C: ABBV-927+ABBV-181 Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.	DRUG: ABBV-927 Intravenous DRUG: ABBV-181 Intravenous

Primary Outcome Measures	Measure Description	Time Frame
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.	Up to 8 weeks
Time to Cmax (Tmax) of ABBV-927	Time to Cmax (Tmax) of ABBV-927.	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.	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.	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.	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.	Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181	Time to Cmax (Tmax) of ABBV-181.	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.	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.	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.	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.	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.	Up to 30 days after and up to 24-month of treatment period

Secondary Outcome Measures	Measure Description	Time Frame
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.	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.	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.	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.	Up to 30 days after and up to 24-month of treatment period

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: ABBVIE INC., AbbVie

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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