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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03595059
• Other study ID #: M16-573
• Secondary ID: 2020-002495-12
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 13, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• ABBV-155
Intravenous (IV) Infusion
• Paclitaxel
Intravenous (IV) Infusion
• Docetaxel
Intravenous (IV) Infusion

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Center /ID# 241676	Melbourne	New South Wales
Canada	Cross Cancer Institute /ID# 213838	Edmonton	Alberta
Canada	Princess Margaret Cancer Centre /ID# 204539	Toronto	Ontario
Israel	Rambam Health Care Campus /ID# 230813	Haifa	H_efa
Israel	The Chaim Sheba Medical Center /ID# 230812	Ramat Gan	Tel-Aviv
Japan	National Cancer Center Hospital /ID# 215003	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East /ID# 215130	Kashiwa-shi	Chiba
Korea, Republic of	National Cancer Center /ID# 241095	Goyang-si	Gyeonggido
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 240648	Seoul	Seoul Teugbyeolsi
Netherlands	Antoni van Leeuwenhoek /ID# 222260	Amsterdam	Noord-Holland
Netherlands	Maastricht Universitair Medisch Centrum /ID# 225220	Maastricht
Netherlands	Erasmus Medisch Centrum /ID# 222341	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht /ID# 222357	Utrecht
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 232128	Rio Piedras
Spain	Hospital Universitario 12 de Octubre /ID# 239999	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 239997	Madrid
Taiwan	China Medical University Hospital /ID# 214062	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 206304	Tainan
Taiwan	National Taiwan University Hospital /ID# 205673	Taipei City
United States	Univ of Colorado Cancer Center /ID# 208365	Aurora	Colorado
United States	Johns Hopkins Bayview Med Cnt /ID# 215095	Baltimore	Maryland
United States	Johns Hopkins Hospital /ID# 201320	Baltimore	Maryland
United States	University of Alabama at Birmingham - Main /ID# 214024	Birmingham	Alabama
United States	Dana-Farber Cancer Institute /ID# 201564	Boston	Massachusetts
United States	Northwestern University Feinberg School of Medicine /ID# 201563	Chicago	Illinois
United States	Univ Hosp Cleveland /ID# 201567	Cleveland	Ohio
United States	Mary Crowley Cancer Research /ID# 214168	Dallas	Texas
United States	Henry Ford Hospital /ID# 226852	Detroit	Michigan
United States	MD Anderson Cancer Center /ID# 201558	Houston	Texas
United States	Carolina BioOncology Institute /ID# 201577	Huntersville	North Carolina
United States	Vanderbilt Ingram Cancer Center /ID# 201575	Nashville	Tennessee
United States	Yale University, Yale Cancer Center /ID# 201542	New Haven	Connecticut
United States	Northwell Health - Marcus Ave /ID# 204376	New Hyde Park	New York
United States	University of Oklahoma, Stephenson Cancer Center /ID# 206820	Oklahoma City	Oklahoma
United States	UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105	Orange	California
United States	AdventHealth Cancer Institute - Orlando /ID# 227242	Orlando	Florida
United States	Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256	Providence	Rhode Island
United States	NEXT Oncology /ID# 204893	San Antonio	Texas
United States	Highlands Oncology Group, PA /ID# 201568	Springdale	Arkansas
United States	Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Japan,  Korea, Republic of,  Netherlands,  Puerto Rico,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to approximately 12 months
Secondary	Duration of Response (DOR)	DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first.	Up to approximately 12 months
Secondary	Rate of Complete Response (CR)	CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1	Up to approximately 2 to 6 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first.	Up to approximately 12 months
Secondary	Overall Survival (OS)	OS is defined as the number of days from the date of first study drug to the date of death due to any cause.	Up to approximately 12 months after last dose of study drug
Secondary	Cmax of ABBV-155	Maximum plasma concentration (Cmax).	Up to approximately 48 days
Secondary	Tmax of ABBV-155	Time to maximum plasma concentration (Tmax).	Up to approximately 48 days
Secondary	Terminal Phase Elimination Rate constant of ABBV-155	Terminal phase elimination rate constant of ABBV-155	Up to approximately 48 days
Secondary	AUCt of ABBV-155	Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).	Up to approximately 48 days
Secondary	AUCinf of ABBV-155	AUC from time 0 to infinite time (AUCinf).	Up to approximately 48 days
Secondary	QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.	Up to approximately 8 days
Secondary	t1/2 of ABBV-155	Terminal elimination half-life (t1/2).	Up to approximately 48 days