NCT03000257

A Study of an Active Drug in Participants With Advanced Solid Tumors

Brief summary

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 an active drug. This study will also evaluate the safety and tolerability of an active drug in combination with an active drug and an active drug in combination with an active drug. The study will consist of 3 parts: an active drug monotherapy dose escalation and expansion, an active drug in combination with an active drug and an active drug in combination with an active drug.

Interventional study

Status:
Recruiting
Conditions:
Advanced Solid Tumors
Enrollment:
221 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-891
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 99 Years.

Inclusion Criteria:

- Participant must have an advanced solid tumor and must not be a candidate for surgical
resection or other approved therapeutic regimen known to provide clinical benefit. For
dose escalation, the participant may have been previously treated with a programmed
cell death 1 (PD-I) targeting agent. For dose expansion, the participant must be
PD-I/PD-L1 targeting agent naïve. For Part 2 ABBV-181 in combination with
rovalpituzumab tesirine, the participant must have SCLC with progressive disease and
have failed platinum containing therapy and be PD-1/PD-L1 targeting agent naïve. For
Part 3 ABBV-181 in combination with venetoclax, the participant must have locally
advanced or metastatic NSCLC and received no more than four lines of therapy in an
advanced or metastatic setting and has progressed on no more than one PD-1/PD-L1
containing therapy.

- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 2 for the monotherapy cohort and an ECOG 0 to 1 for ABBV-181 in combination with
rovalpituzumab tesirine cohort (Part 2) and ABBV-181 in combination with venetoclax
(Part 3).

- Participants have adequate bone marrow, renal, hepatic and coagulation function.

- Participants must have measurable or evaluable disease per Response Evaluation
Criteria in Solid Tumors (RECIST) version 1.1 in the dose escalation portion of the
trial. Participants in the expansion cohort must have measurable disease per RECIST
version 1.1 or disease evaluable by assessment of tumor antigens. Participants
enrolled in ABBV-181 in combination with venetoclax cohort (Part 3) must have
measurable disease per RECIST version 1.1.

Exclusion Criteria:

- Participant has received anticancer therapy including chemotherapy, immunotherapy,
radiation therapy, biologic, herbal therapy, or any investigational therapy within a
period of 5 half-lives, prior to the first dose of ABBV-181 or Rovalpituzumab Tesirine
or venetoclax.

- For ABBV-181 plus rovalpituzumab tesirine therapy (Part 2), participant must not have
had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based
drug.

- Participant has unresolved adverse events greater than grade 1 from prior anticancer
therapy except for alopecia.

- 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 A, B or C. Subjects who have a history
of hepatitis B or C who have undetectable HBV DNA or HCV RNA are anti-viral therapy
may be enrolled.

- Participant has known history or inflammatory bowel disease, pneumonitis, or known
uncontrolled metastases to the central nervous system (CNS) (with certain exceptions).

- Participants with a history of or ongoing pneumonitis or interstitial lung disease are
also excluded.

- For ABBV-181 plus venetoclax therapy (Part 3), participant must not receive a strong
or moderate inducer or inhibitor of cytochrome P450 (CYP)3A within 7 days before first
venetoclax dose.

- For ABBV-181 plus venetoclax therapy (Part 3), participants with a known
gastrointestinal disorder (i.e.: malabsorption syndrome), complication (i.e.:
dysphagia) or surgery that could make consumption or absorption of oral medication
problematic are also excluded.

All the cities where the clinical studies are located

Edmonton - T6G 1Z2

Alberta