A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers

NCT04272203 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: M19-7472019-003434-16
• Study Type: interventional
• Target: 14
• Locations: 5 countries
• Sites: 17

Brief Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC. ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries. Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time. There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.

Conditions

Acute Myeloid Leukemia (AML); Non Small Cell Lung Cancer; Cancer

Keywords

Advanced Solid Tumors Cancer; Acute Myeloid Leukemia (AML); Non Small Cell Lung Cancer (NSCLC); Blood Cancer; ABBV-184; Cancer

Outcome Measures

Primary Outcomes (3)

• Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase)

  The RP2D of ABBV-184 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.

  Up to 1 Cycle after the last participant is enrolled in dose escalation phase (Approximately 2 years)

• Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) Rate (Dose Expansion Phase in Participants With AML)

  CR/CRh rate is assessed based on the Clopper-Pearson (exact) method.

  Up to 30 days after last participant complete study drug (Approximately 3 years)

• Objective Response Rate (ORR) (Dose Expansion Phase in Participants With NSCLC)

  ORR is defined as participants with confirmed complete or partial response (CR+PR) per RECIST, v1.1

  Up to 30 days after last participant complete study drug (Approximately 3 years)

Secondary Outcomes (20)

• Number of Participants with Adverse Events (AEs)

  Up to 30 days after last participant complete study drug (Approximately 3 years)

• Change in Laboratory Parameters

  Up to 30 days after last participant complete study drug (Approximately 3 years)

• Change in Vital Signs

  Up to 30 days after last participant complete study drug (Approximately 3 years)

• Change in Montreal Cognitive Assessment (MoCA)

  Up to 30 days after last participant complete study drug (Approximately 3 years)

• Change in Echocardiogram

  Up to 30 days after last participant complete study drug (Approximately 3 years)

Study Arms (4)

Dose Escalation: Participants With AML

EXPERIMENTAL

Participants with relapsed or refractory (R/R) AML will receive escalating doses of ABBV-184

Drug: ABBV-184

Dose Escalation: Participants With NSCLC

EXPERIMENTAL

Participants with relapsed or refractory (R/R) NSCLC will receive escalating doses of ABBV-184

Drug: ABBV-184

Dose Expansion: Participants With AML

EXPERIMENTAL

Participants with R/R AML will receive ABBV-184 at recommended Phase 2 dose (RP2D) determined in dose escalation phase for AML

Drug: ABBV-184

Dose Expansion: Participants With NSCLC

EXPERIMENTAL

Participants with R/R NSCLC will receive ABBV-184 at RP2D determined in dose escalation phase for NSCLC

Drug: ABBV-184

Interventions

ABBV-184 DRUG

Intravenous (IV) infusion

Dose Escalation: Participants With AML; Dose Escalation: Participants With NSCLC; Dose Expansion: Participants With AML; Dose Expansion: Participants With NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute myeloid leukemia (AML) or non-small cell lung cancer (NSCLC).
• Participants must consent to hospitalization for at least 72 hours following the first two doses of ABBV-184 in Cycle 1.
• Participants must have Human Leukocyte Antigen-A2 (HLA-A2) restricted genotype. Participants must be HLA-A2:01 positive in at least one allele tested with a high-resolution HLA genotyping assay performed in a College of American Pathologists (CAP)/Clinical Laboratory Improvement Act (CLIA)-certified or equivalent laboratory.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Laboratory values and cardiac function must meet the protocol specifications.

You may not qualify if:

• For AML participants:
• Presence or history of extramedullary disease are ineligible, participants with a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia are not eligible.
• For NSCLC participants:
• Tumors with epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) gene rearrangements are not eligible.
• Active/uncontrolled central nervous system (CNS) leukemia/lung cancer are not eligible for the study.
• History of inflammatory bowel disease, interstitial lung disease (pneumonitis), myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis, solid organ transplantation, active autoimmune disease (with exceptions of vitiligo, Type I diabetes mellitus, hypothyroidism, and psoriasis), primary immunodeficiency.
• History of clinical diagnosis of tuberculosis or major immunologic reaction to any immunoglobulin G (IgG)-containing agent are not eligible.
• Previously received anti-cancer treatment with an agent that targets the immune system by engaging cluster of differentiation 3 (CD3) are not eligible.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (17)

Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332

Fort Wayne, Indiana, 46804, United States

Location

Gabrail Cancer Center Research /ID# 215667

Canton, Ohio, 44718, United States

Location

Thomas Jefferson University /ID# 218403

Philadelphia, Pennsylvania, 19107-4414, United States

Location

Centre Antoine Lacassagne - Nice /ID# 218014

Nice, Alpes-Maritimes, 06189, France

Location

CHU Bordeaux - Hopital Haut Leveque /ID# 224998

Pessac, Gironde, 33604, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 217508

Lille, Hauts-de-France, 59037, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 215703

Nantes, Pays de la Loire Region, 44000, France

Location

Hopital Saint-Andre /ID# 224218

Bordeaux, 33075, France

Location

The Chaim Sheba Medical Center /ID# 215810

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 222749

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 215808

Haifa, 3109601, Israel

Location

Aichi Cancer Center Hospital /ID# 216469

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East /ID# 216467

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital /ID# 216466

Chuo-ku, Tokyo, 104-0045, Japan

Location

Oxford University Hospitals NHS Foundation Trust /ID# 217252

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Cardiff & Vale University Health Board /ID# 217250

Cardiff, Wales, CF14 4XN, United Kingdom

Location

The Christie Hospital /ID# 216118

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Peterlin P, Saada-Bouzid E, Moskovitz M, Pigneux A, Yuda J, Sinnollareddy M, Henner WR, Chen D, Freise KJ, Leibman RS, Avigdor A, Shimizu T. First-in-human clinical trial results with ABBV-184, a first-in-class T-cell receptor/anti-CD3 bispecific protein, in adults with previously treated AML or NSCLC. Expert Rev Anticancer Ther. 2024 Sep;24(9):893-904. doi: 10.1080/14737140.2024.2373888. Epub 2024 Jul 10.

  PMID: 38946484 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Carcinoma, Non-Small-Cell Lung; Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: May 5, 2020
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3); GB (3); US (3); IL (3); FR (5)