A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors Cancer
In brief
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Key facts
- Study ID
- NCT03071757
- Run by
- AbbVie
- People needed
- 139
- Starts
- 2017-03-21
- Expected to finish
- 2022-04-13
- Last updated by the study team
- 2022-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must have histologic or cytology diagnosis of a known immunogenic solid tumor, as described for Part 1 Dose Escalation and Part 2 Cohort Expansion:
- Part 1 Dose Escalation:
- Participants with advanced or metastatic solid tumors that have exhausted standard treatment for their incurable disease and for whom there is currently no programmed cell death 1 (PD-1)/ programmed cell death-ligand 1 (PD-L1) approved therapy, with immunogenic type tumors such as, but not limited to triple negative breast cancer (TNBC), ovarian cancer, small cell lung cancer, mesothelioma, and cholangiocarcinoma.
- Participants who are refractory to a PD-1/PD-L1 agent, with tumor types such as melanoma, NSCLC, platinum-pretreated head and neck cancer, second line bladder and RCC.
- Part 2A and 2B Cohort Expansion:
- 2A : TNBC ABBV-368 monotherapy cohorts: Subjects with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease.
- 2B : Head and Neck cohort: Participants with recurrent squamous cell head and neck carcinoma that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- Part 3A and 3B Imaging Substudy:
- 3A: Participants with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease and are treatment naïve to a PD-1/PD-L1 targeting agent.
- 3B: Participants with recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. Participants must be treatment naïve to a PD-1/PD-L1 targeting agent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Participants must have immune-related Response Evaluation Criteria for Solid Tumors (iRECIST) evaluable or measurable disease in the PART 1 and measurable disease per iRECIST in PART 2
- Adequate bone marrow, kidney and liver function.
You may not qualify if…
- Received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 21 days prior to the first dose of ABBV-368.
- Prior treatment with an OX40 targeting agent.
- has known uncontrolled metastases to the central nervous system (CNS).
- History of active autoimmune disorders and other conditions that compromise or impair the immune system.
- Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active hepatitis A, B or C. Subjects who have a history of hepatitis B or C who have documented cures after anti-viral therapy may be enrolled.
- Has received live vaccine within 28 days prior to the first dose of study drug.
Where it is running
- Moores Cancer Center at UC San Diego /ID# 201334 — La Jolla, California, United States
- University of California, Davis Comprehensive Cancer Center /ID# 201342 — Sacramento, California, United States
- Stanford University /ID# 206949 — Stanford, California, United States
- Yale University /ID# 207895 — New Haven, Connecticut, United States
- Carolina BioOncology Institute /ID# 160786 — Huntersville, North Carolina, United States
- Greenville Hospital System /ID# 160785 — Greenville, South Carolina, United States
- University of Texas Southwestern Medical Center /ID# 201934 — Dallas, Texas, United States
- South Texas Accelerated Research Therapeutics /ID# 160788 — San Antonio, Texas, United States
- University of Virginia /ID# 212895 — Charlottesville, Virginia, United States
- Virginia Cancer Specialists - Fairfax /ID# 160787 — Fairfax, Virginia, United States
- AP-HM - Hopital de la Timone /ID# 165036 — Marseille, Bouches-du-Rhone, France
- Centre Leon Berard /ID# 165037 — Lyon, Rhone, France
- Institut Gustave Roussy /ID# 165035 — Villejuif, Val-de-Marne, France
- Institut Curie /ID# 165038 — Paris, Île-de-France Region, France
- National Cancer Center Hospital East /ID# 214530 — Kashiwa-shi, Chiba, Japan
- National Cancer Center Hospital /ID# 214531 — Chuo-ku, Tokyo, Japan
- Pan American Center for Oncology Trials, LLC /ID# 213809 — Rio Piedras, Puerto Rico
- Hospital Duran i Reynals /ID# 205997 — L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973 — Majadahonda, Madrid, Spain
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879 — Pamplona, Navarre, Spain
- Hospital General Universitario Gregorio Maranon /ID# 205999 — Madrid, Spain
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996 — Madrid, Spain
- Hospital Universitario Fundacion Jimenez Diaz /ID# 211500 — Madrid, Spain
- Hospital Clinico Universitario de Valencia /ID# 211499 — Valencia, Spain
- National Cheng Kung University Hospital /ID# 164002 — Tainan, Taiwan
Full record on ClinicalTrials.gov
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