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

NCT02988960 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: M15-8622016-002219-16
• Study Type: interventional
• Target: 163
• Locations: 7 countries
• Sites: 22

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.

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; Budigalimab

Outcome Measures

Primary Outcomes (12)

• 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 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)

  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

Study Arms (9)

Escalating Arm 1: ABBV-927

EXPERIMENTAL

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

Drug: ABBV-927

Escalating Arm 2: ABBV-927

EXPERIMENTAL

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

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.

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.

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.

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.

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.

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.

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.

Drug: ABBV-927; Drug: ABBV-181

Interventions

ABBV-927 DRUG

Intravenous

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-181 DRUG

Intravenous

Also known as: Budigalimab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (22)

The Angeles Clinic and Researc /ID# 156324

Los Angeles, California, 90025, United States

Location

The University of Chicago Medical Center /ID# 155264

Chicago, Illinois, 60637-1443, United States

Location

Massachusetts General Hospital /ID# 155267

Boston, Massachusetts, 02114, United States

Location

Carolina BioOncology Institute /ID# 155265

Huntersville, North Carolina, 28078, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 158654

Nashville, Tennessee, 37203-1632, United States

Location

University of Texas MD Anderson Cancer Center /ID# 155263

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 155266

Fairfax, Virginia, 22031, United States

Location

Peninsula Oncology Centre /ID# 164372

Frankston, Victoria, 3199, Australia

Location

Austin Health /ID# 171189

Heidelberg, Victoria, 3084, Australia

Location

University Health Network_Princess Margaret Cancer Centre /ID# 200819

Toronto, Ontario, M5G 2M9, Canada

Location

Institut Bergonie /ID# 162665

Bordeaux, Gironde, 33000, France

Location

Duplicate_Institut Regional du Cancer /ID# 163609

Montpellier, Herault, 34298, France

Location

Centre Leon Berard /ID# 162663

Lyon, Rhone, 69373, France

Location

Institut Gustave Roussy /ID# 162666

Villejuif, Val-de-Marne, 94805, France

Location

National Cancer Center Hospital East /ID# 216870

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital /ID# 217758

Chuo-ku, Tokyo, 104-0045, Japan

Location

Seoul National University Hospital /ID# 166291

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 166292

Seoul, 03722, South Korea

Location

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 200127

Madrid, 28050, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 200975

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Melanoma

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: February 22, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); FR (4); JP (2); CA (1); KR (2); ES (4); AU (2)