A Study of the Safety and Activity of Experimental ABBV-368 for Advanced Solid Tumors

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: cancer, advanced solid tumors, metastatic solid tumors
Type: Drug study, Phase 1
Target:
5 Participants
Investigator:
Description
Purpose of Study:
- To see if the study drug is safe and tolerable for subjects with locally advanced solid tumors
- To find out the side-effects of ABBV-368 alone and combined with ABBV-181 in patients with advanced solid tumors
- To find out how your body handles ABBV-368 alone and in combination with ABBV-181
- To decide on the dose of ABBV-368 that will be best to use in future studies
- To find out if substances (biomarkers) found in your blood or tumor tissue may show the effects or progress of the cancer and the activity ABBV-368 has on it
- To help explain how to improve the treatment and/or diagnosis of cancer

Purpose of Biomarker and Exploratory Research
- To find out why some patients with the disease being studied respond better or worse to the study drug or drugs of the same or similar class
- To find out how the disease being studied and related conditions develop and progress and how they can be diagnosed, monitored, or treated
- To develop tests to identify which patients are likely to have different diseases, respond to the study drug or drugs of the same or similar class, or to predict the progression of the disease being studied
- To possibly develop new therapies, research methods, or technologies
- To understand the drug effects on the body and immune system Every participant in the main study will be asked to provide samples for optional exploratory research.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The length of time on the study will depend on the status of your cancer. It may also depend on the effects of ABBV-368 and other side effects you may experience form taking this investigational study drug. You will continue to receive drug until your disease progresses, you have adverse events or withdraw consent.
Recruitment period
From March 6, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Frances Lara
Research Topic
Conditions:
  • Advanced Solid Tumors Cancer