A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

NCT03595059 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: M16-5732020-002495-12
• Study Type: interventional
• Target: 168
• Locations: 10 countries
• Sites: 40

Brief Summary

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

Conditions

Advanced Solid Tumors

Keywords

Cancer; Advanced Solid Tumors; Relapsed and/or Refractory Solid Tumors; ABBV-155; Taxane; Paclitaxel; Docetaxel; breast cancer; non-small cell lung cancer (NSCLC); small cell lung cancer (SCLC)

Outcome Measures

Primary Outcomes (2)

• MTD and/or RPTD of ABBV-155

  The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).

  Up to approximately 21 days after initial dose of study drug

• Overall Response Rate (ORR)

  ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to approximately 2 to 6 months

Secondary Outcomes (12)

• Number of Participants with Adverse Events (AE)

  Up to approximately 12 months

• Duration of Response (DOR)

  Up to approximately 12 months

• Rate of Complete Response (CR)

  Up to approximately 2 to 6 months

• Progression-Free Survival (PFS)

  Up to approximately 12 months

• Overall Survival (OS)

  Up to approximately 12 months after last dose of study drug

Study Arms (5)

Escalation 1a: ABBV-155

EXPERIMENTAL

Participants will be administered ABBV-155 (various doses).

Drug: ABBV-155

Escalation 1b: ABBV-155 + paclitaxel or docetaxel

EXPERIMENTAL

Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .

Drug: ABBV-155; Drug: Paclitaxel; Drug: Docetaxel

Expansion 2a: ABBV-155 in SCLC

EXPERIMENTAL

Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).

Drug: ABBV-155

Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer

EXPERIMENTAL

Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.

Drug: ABBV-155; Drug: Paclitaxel

Expansion 2b: ABBV-155 + docetaxel in NSCLC

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.

Drug: ABBV-155; Drug: Docetaxel

Interventions

ABBV-155 DRUG

Intravenous (IV) Infusion

Escalation 1a: ABBV-155; Escalation 1b: ABBV-155 + paclitaxel or docetaxel; Expansion 2a: ABBV-155 in SCLC; Expansion 2b: ABBV-155 + docetaxel in NSCLC; Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer

Paclitaxel DRUG

Intravenous (IV) Infusion

Escalation 1b: ABBV-155 + paclitaxel or docetaxel; Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer

Docetaxel DRUG

Intravenous (IV) Infusion

Escalation 1b: ABBV-155 + paclitaxel or docetaxel; Expansion 2b: ABBV-155 + docetaxel in NSCLC

Eligibility Criteria

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

You may qualify if:

• Has a histologic or cytologic diagnosis of a malignant solid tumor.
• Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung cancer (SCLC) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC or HR-positive/HER2-negative breast cancer.
• Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Failure of at least 1 prior systemic chemotherapy including all available standard therapies for participants in the dose-escalation phase (Parts 1a and 1b) including the safety lead-in phase (Japan only).
• All participants with breast cancer for subjects in the dose-expansion phase (Part 2b only) must have the following:
• Locally advanced or metastatic HR-positive/HER2-negative breast cancer after failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.
• HR-positivity and HER-2-negativity should be confirmed based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria.
• All participants with non-small cell lung cancer (NSCLC) for participants in the dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line of therapy. Participants with activating mutations in EGFR, ALK/ROS1, BRAF genes, or with positive expression of PD-L1 must have been treated with the appropriate targeted therapies.
• All participants with SCLC in the dose-expansion phase (Part 2a only) must have R/R SCLC from at least 1 line of therapy which includes a platinum-based therapy with or without an anti-PD-1/PD-L1 therapy.
• All participants with either breast cancer or NSCLC must have the following if exposed to prior taxane-based therapy:
• No history of taxane allergy (Part 1b and Part 2b only).
• Disease that has relapsed or progressed at least 2 months after most recent exposure to any taxane-based therapy.
• Available tumor tissue suitable for immunohistochemistry testing.
• Adequate kidney, liver, and hematologic laboratory values as described in the protocol.

You may not qualify if:

• Untreated brain or meningeal metastases (participants with a history of metastases may be eligible based on details described in the protocol).
• Grade 2 or higher peripheral neuropathy (only applies to participants who would receive taxane therapy).
• Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
• Known active infection of hepatitis B, hepatitis C, or human immunodeficiency virus with exceptions as described in the protocol.
• Recent history (within 6 months) of congestive heart failure (defined in the protocol), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
• Any history of hypersensitivity to any ingredients of ABBV-155 will be excluded. For combination therapy only (Parts 1b and 2b), no history of serious allergic reaction to any taxane or any ingredients used in taxane formulation (e.g., cremaphor).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (40)

University of Alabama at Birmingham - Main /ID# 214024

Birmingham, Alabama, 35233, United States

Location

Highlands Oncology Group, PA /ID# 201568

Springdale, Arkansas, 72762, United States

Location

UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105

Orange, California, 92868-3201, United States

Location

Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267

West Hollywood, California, 90048, United States

Location

Univ of Colorado Cancer Center /ID# 208365

Aurora, Colorado, 80045, United States

Location

Yale University, Yale Cancer Center /ID# 201542

New Haven, Connecticut, 06510-3206, United States

Location

AdventHealth Orlando /ID# 227242

Orlando, Florida, 32803, United States

Location

Northwestern University Feinberg School of Medicine /ID# 201563

Chicago, Illinois, 60611-2927, United States

Location

Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital /ID# 201320

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute /ID# 201564

Boston, Massachusetts, 02215, United States

Location

Duplicate_Henry Ford Hospital /ID# 226852

Detroit, Michigan, 48202, United States

Location

Northwell Health - Marcus Ave /ID# 204376

New Hyde Park, New York, 11042-2060, United States

Location

Carolina BioOncology Institute /ID# 201577

Huntersville, North Carolina, 28078, United States

Location

Univ Hosp Cleveland /ID# 201567

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma, Stephenson Cancer Center /ID# 206820

Oklahoma City, Oklahoma, 73104-5418, United States

Location

Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256

Providence, Rhode Island, 02903-4923, United States

Location

Vanderbilt Ingram Cancer Center /ID# 201575

Nashville, Tennessee, 37232-0021, United States

Location

Mary Crowley Cancer Research /ID# 214168

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center /ID# 201558

Houston, Texas, 77030, United States

Location

NEXT Oncology /ID# 204893

San Antonio, Texas, 78229, United States

Location

Peter MacCallum Cancer Center /ID# 241676

Melbourne, New South Wales, 3000, Australia

Location

Duplicate_Cross Cancer Institute /ID# 213838

Edmonton, Alberta, T6G 1Z2, Canada

Location

University Health Network_Princess Margaret Cancer Centre /ID# 204539

Toronto, Ontario, M5G 2M9, Canada

Location

The Chaim Sheba Medical Center /ID# 230812

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Campus /ID# 230813

Haifa, 3109601, Israel

Location

National Cancer Center Hospital East /ID# 215130

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital /ID# 215003

Chuo-ku, Tokyo, 104-0045, Japan

Location

Maastricht Universitair Medisch Centrum /ID# 225220

Maastricht, Limburg, 6229 HX, Netherlands

Location

Antoni van Leeuwenhoek /ID# 222260

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Erasmus Medisch Centrum /ID# 222341

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 222357

Utrecht, 3584 CX, Netherlands

Location

Pan American Center for Oncology Trials, LLC /ID# 232128

Rio Piedras, 00935, Puerto Rico

Location

National Cancer Center /ID# 241095

Goyang-si, Gyeonggido, 10408, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 240648

Seoul, 03722, South Korea

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 239997

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre /ID# 239999

Madrid, 28041, Spain

Location

National Taiwan University Hospital /ID# 205673

Taipei City, Taipei, 100, Taiwan

Location

China Medical University Hospital /ID# 214062

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital /ID# 206304

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: July 13, 2018
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); US (21); AU (1); TW (3); CA (2); NL (4); KR (2); IL (2); PR (1); JP (2)