A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

AbbVie

Status and phase: Completed; Phase 1

Conditions: Non-Hodgkins Lymphoma; Breast Cancer; Multiple Myeloma; Small Cell Lung Cancer; Acute Myeloid Leukemia (AML); Cancer; Prostate Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: Venetoclax; Drug: ABBV-075

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391480

M14-546

Details and patient eligibility

About

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
2. Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
4. Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
5. Adequate bone marrow, renal, and hepatic function.
6. QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion criteria

1. Participant has untreated brain or meningeal metastases.
2. Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1.
3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
4. Symptoms of gross hematuria or gross hemoptysis.
5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
6. History of long QT syndrome.
7. Peripheral neuropathy greater than or equal to grade 2.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 3 patient groups

ABBV-075

Experimental group

Description:

Dose escalation cohorts of ABBV-075 monotherapy

Treatment:

Drug: ABBV-075

ABBV-075 and venetoclax combination

Experimental group

Description:

Expansion cohorts of ABBV-075 and venetoclax combination therapy

Treatment:

Drug: ABBV-075

Drug: Venetoclax

ABBV-075 expansion

Experimental group

Description:

Expansion cohorts of ABBV-075 monotherapy

Treatment:

Drug: ABBV-075