A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

AbbVie

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors Cancer

Treatments: Drug: ABBV-428; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02955251

M15-819

2016-001461-88 (EudraCT Number)

Details and patient eligibility

About

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Enrollment: 61 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants 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 have adequate bone marrow, renal, hepatic and coagulation function.
• For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
• Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

Exclusion criteria

• Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
• History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
• Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
• Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
• Male participants who are 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

61 participants in 4 patient groups

Arm 1

Experimental group

Description:

ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).

Treatment:

Drug: ABBV-428

Arm A, B, and C

Experimental group

Description:

Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.

Treatment:

Drug: ABBV-428

Arm D

Experimental group

Description:

Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.

Treatment:

Drug: Nivolumab

Drug: ABBV-428

Arm 2

Experimental group

Description:

ABBV-428 plus nivolumab.

Treatment:

Drug: Nivolumab

Drug: ABBV-428