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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

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

Intervention / Treatment
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* Drug: ABBV-085


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 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). All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies. Participant has adequate bone marrow, renal, hepatic and cardiac function. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. Exclusion Criteria: Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085. 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. Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia. Participant has ongoing hemolysis. Major surgery within <=28 days prior to the first dose of ABBV-085. Clinically significant uncontrolled condition(s). Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A4 (ABBV-085)<br>ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson | Drug: ABBV-085<br>* Administered as an intravenous infusion in 28-day dosing cycles.<br>|
| Experimental: Arm A3 (ABBV-085)<br>ABBV-085 will be administered at every cycle (28-day cycles). | Drug: ABBV-085<br>* Administered as an intravenous infusion in 28-day dosing cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal elimination half life of ABBV-085. |  | UP to 24 months | 
| Maximum observed plasma concentration (Cmax) of ABBV-085. |  | Up to 24 months | 
| Number of participants with Adverse Events | Collect all adverse events at each visit. | Up to 24 months | 
| Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. | AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration. | Up 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR). | Up to 24 months | 
| Progression free survival (PFS) | PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first. | Up to 24 months | 
| Duration of overall response (DOR) | DOR is defined as the time from the participant's initial CR or PR to the time of disease progression. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate