Advanced Solid Tumors, Carcinoma of the Breast, Squamous Cell Carcinoma of the Head and Neck, Undifferentiated Pleomorphic Sarcoma
Conditions
Keywords
Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate
Brief summary
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.
Interventions
DRUGABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 24 months | Collect all adverse events at each visit. |
| Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. | Up 24 months | AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to 24 months | PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first. |
| Duration of overall response (DOR) | Up to 24 months | DOR is defined as the time from the participant's initial CR or PR to the time of disease progression. |
| Objective response rate (ORR) | Up to 24 months | ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR). |
Countries
France, Spain, United States
Outcome results
None listed