A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously Treated Solid Tumors and Hematologic Malignancies

  • Interventional
  • Recruiting
  • NCT03082209
Eligibility Details Visit Clinicaltrials.gov

An Open-Label, Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously Treated Solid Tumors and Hematologic Malignancies

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously treated solid tumors or hematologic malignancies.

Gender
All

Age Group
18 Years to 100 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Must have a diagnosis of a solid tumor (except primary brain tumors), acute myeloid leukemia (AML), or non-Hodgkin lymphoma (NHL); NHL may be of any subtype for Dose Escalation but is limited to diffuse large B-cell lymphoma (DLBCL) for those enrolled to the cohort evaluating the combination of ABBV-621 and venetoclax. Subjects in the Dose Optimization solid tumor cohorts must have either colorectal cancer with documented KRAS mutations (as determined by local testing), or pancreatic cancer (irrespective of mutational status).

         - Participant in dose escalation or dose optimization cohort must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.

         - Must have measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 for those with solid tumors; by Lugano classification for those with NHL), except those with AML, who must have histologically confirmed relapsed or refractory disease.

         - Must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 2. Participants in chemotherapy combination cohorts must have ECOG Performance Score of 0 - 1.

         - Must have adequate hematologic, renal and hepatic function.

         - Participants in chemotherapy combination cohorts must have metastatic or advanced unresectable colorectal cancer with documented KRAS mutation or pancreatic adenocarcinoma.

         - Participant in chemotherapy combination cohort with pancreatic adenocarcinoma must be treatment naive.

        Exclusion Criteria:

         - Participants with history of brain metastases who have not shown clinical and radiographic stable disease for at least 28 days after definitive therapy.

         - Presence of primary hepatobiliary malignancy, including cholangiocarcinoma or hepatocellular carcinoma, gallbladder carcinoma, cancer of ampulla of Vater.

         - Receipt of any systemic anti-cancer agent, including investigational anti-cancer products, within 21 days prior to study drug administration or 3 half-lives, whichever is longer.

         - Participant with a history of cirrhosis or other indication of significant possible hepatic dysfunction. Note: Those with non-alcoholic steatohepatitis (NASH) should be discussed with the AbbVie TA MD before enrollment.

         - Participant with a positive diagnosis of hepatitis A, B, or C.

         - CRC chemotherapy cohort only: Participant with minor surgical procedures, such as fine needle aspirations or core biopsies, within 7 days prior to first dose of study drug are excluded.

         - Participants in CRC chemotherapy combination cohort only: cardiomyopathy, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, pulmonary hypertension, cerebrovascular accident or transient ischemic attack, within 1 year of first dose of study drug.

         - Chemotherapy combination pancreatic adenocarcinoma participants only: history of pneumonitis.

         - Chemotherapy combination CRC participants only: Prior receipt of an irinotecan-based chemotherapy.

         - Chemotherapy combination CRC participants only: history of Gilbert's syndrome or UG1T1A1 genotypes.

         - Chemotherapy Combination CRC Participants Only: Clinically significant conditions that may place the participant at higher risk with anti-angiogenic therapy.

At a Glance

National Government IDNCT03082209

IRB#IRB16-1743

Lead SponsorAbbVie

Lead PhysicianMark J. Ratain

Collaborator(s)N/A

EligibilityAll
18 Years to 100 Years
Recruiting