ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

AbbVie

Status and phase: Completed; Phase 1

Conditions: Carcinoma of the Breast; Squamous Cell Carcinoma of the Head and Neck; Advanced Solid Tumors; Undifferentiated Pleomorphic Sarcoma

Treatments: Drug: ABBV-085

Study type: Interventional

Funder types: Industry

Identifiers

NCT02565758

2015-001645-84 (EudraCT Number)

M15-394

Details and patient eligibility

About

This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

3. Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:

   • Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).

4. All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.

5. Participant has adequate bone marrow, renal, hepatic and cardiac function.

6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.

Exclusion criteria

1. Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
2. Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-085.
3. Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
4. Participant has ongoing hemolysis.
5. Major surgery within <=28 days prior to the first dose of ABBV-085.
6. Clinically significant uncontrolled condition(s).
7. Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Arm A4 (ABBV-085)

Experimental group

Description:

ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson

Treatment:

Drug: ABBV-085

Arm A3 (ABBV-085)

Experimental group

Description:

ABBV-085 will be administered at every cycle (28-day cycles).

Treatment:

Drug: ABBV-085