A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

Sponsors

Lead Sponsor: AbbVie

Source AbbVie
Brief 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 solid tumors.

Overall Status Recruiting
Start Date February 22, 2017
Completion Date November 22, 2021
Primary Completion Date November 22, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure 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 Up to 8 weeks
Time to Cmax (Tmax) of ABBV-927 Up to 12 weeks after participant's first dose
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 Up to 12 weeks after participant's first dose
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 Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181 Up to 12 weeks after participant's first dose
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 Up to 12 weeks after participant's first dose
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 Up to 12 weeks after participant's first dose
Number of Participants with Adverse Events Up to 30 days after and up to 24-month of treatment period
Secondary Outcome
Measure 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) Up to 30 days after and up to 24-month of treatment period
Duration of objective response (DOR) Up to 30 days after and up to 24-month of treatment period
Objective response rate (ORR) Up to 30 days after and up to 24-month of treatment period
Progression-free survival (PFS) Up to 30 days after and up to 24-month of treatment period
Enrollment 216
Condition
Intervention

Intervention Type: Drug

Intervention Name: ABBV-927

Description: Intravenous

Intervention Type: Drug

Intervention Name: ABBV-927

Description: Intratumoral

Intervention Type: Drug

Intervention Name: ABBV-181

Description: Intravenous

Other Name: Budigalimab

Eligibility

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Overall Contact

Last Name: ABBVIE CALL CENTER

Phone: 847.283.8955

Email: [email protected]

Location
Facility: Status:
The Angeles Clinic and Researc /ID# 156324 | Los Angeles, California, 90025, United States Recruiting
University of Chicago DCAM /ID# 155264 | Chicago, Illinois, 60637-1443, United States Recruiting
Massachusetts General Hospital /ID# 155267 | Boston, Massachusetts, 02114, United States Recruiting
Carolina BioOncology Institute /ID# 155265 | Huntersville, North Carolina, 28078, United States Recruiting
Tennessee Oncology-Nashville Centennial /ID# 158654 | Nashville, Tennessee, 37203-1632, United States Recruiting
University of Texas MD Anderson Cancer Center /ID# 155263 | Houston, Texas, 77030, United States Recruiting
Virginia Cancer Specialists /ID# 155266 | Fairfax, Virginia, 22031, United States Recruiting
Peninsula & South Eastern Haem /ID# 164372 | Frankston, Victoria, 3199, Australia Recruiting
Austin Health /ID# 171189 | Melbourne, Victoria, 3084, Australia Recruiting
Princess Margaret Cancer Centre /ID# 200819 | Toronto, Ontario, M5G 2M9, Canada Recruiting
Institut Bergonie /ID# 162665 | Bordeaux, Gironde, 33000, France Recruiting
Institut Regional du Cancer /ID# 163609 | Montpellier CEDEX 5, Herault, 34298, France Recruiting
Gustave Roussy /ID# 162666 | Villejuif, Ile-de-France, 94805, France Recruiting
Centre Leon Berard /ID# 162663 | Lyon CEDEX 08, Rhone, 69373, France Recruiting
National Cancer Center Hospital East /ID# 216870 | Kashiwa-shi, Chiba, 277-8577, Japan Recruiting
National Cancer Center Hospital /ID# 217758 | Chuo-ku, Tokyo, 104-0045, Japan Recruiting
Yonsei University Health System, Severance Hospital /ID# 166292 | Seodaemun-gu, Seoul Teugbyeolsi, 03722, Korea, Republic of Recruiting
Seoul National University Hospital /ID# 166291 | Seoul, 03080, Korea, Republic of Recruiting
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129 | Majadahonda, Madrid, 28222, Spain Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 200128 | Madrid, 28040, Spain Recruiting
Hospital Universitario HM Sanchinarro /ID# 200127 | Madrid, 28050, Spain Recruiting
Hospital Universitario y Politecnico La Fe /ID# 200975 | Valencia, 46026, Spain Recruiting
Location Countries

Australia

Canada

France

Japan

Korea, Republic of

Spain

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 9
Arm Group

Label: Escalating Arm 1: ABBV-927

Type: Experimental

Description: Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Label: Escalating Arm 2: ABBV-927

Type: Experimental

Description: Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.

Label: Escalating Arm 3: ABBV-927+ABBV-181

Type: Experimental

Description: Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Label: Escalating Arm 4: ABBV-927+ABBV-181

Type: Experimental

Description: Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.

Label: Escalating Arm 5 (Japan): ABBV-927

Type: Experimental

Description: Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Label: Escalating Arm 6 (Japan): ABBV-927+ABBV-181

Type: Experimental

Description: Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Label: Expansion Arm A: ABBV-927

Type: Experimental

Description: Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.

Label: Expansion Arm B: ABBV-927+ABBV-181

Type: Experimental

Description: Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.

Label: Expansion Arm C: ABBV-927+ABBV-181

Type: Experimental

Description: Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov