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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03595059




Registration number
NCT03595059
Ethics application status
Date submitted
12/07/2018
Date registered
23/07/2018
Date last updated
3/05/2024

Titles & IDs
Public title
A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2020-002495-12
Secondary ID [2] 0 0
M16-573
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-155
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Docetaxel

Experimental: Escalation 1a: ABBV-155 - Participants will be administered ABBV-155 (various doses).

Experimental: Escalation 1b: ABBV-155 + paclitaxel or docetaxel - Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .

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

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

Experimental: Expansion 2b: ABBV-155 + docetaxel in NSCLC - 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.


Treatment: Drugs: ABBV-155
Intravenous (IV) Infusion

Treatment: Drugs: Paclitaxel
Intravenous (IV) Infusion

Treatment: Drugs: Docetaxel
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MTD and/or RPTD of ABBV-155
Timepoint [1] 0 0
Up to approximately 21 days after initial dose of study drug
Primary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 2 to 6 months
Secondary outcome [1] 0 0
Number of Participants with Adverse Events (AE)
Timepoint [1] 0 0
Up to approximately 12 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 12 months
Secondary outcome [3] 0 0
Rate of Complete Response (CR)
Timepoint [3] 0 0
Up to approximately 2 to 6 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Up to approximately 12 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 12 months after last dose of study drug
Secondary outcome [6] 0 0
Cmax of ABBV-155
Timepoint [6] 0 0
Up to approximately 48 days
Secondary outcome [7] 0 0
Tmax of ABBV-155
Timepoint [7] 0 0
Up to approximately 48 days
Secondary outcome [8] 0 0
Terminal Phase Elimination Rate constant of ABBV-155
Timepoint [8] 0 0
Up to approximately 48 days
Secondary outcome [9] 0 0
AUCt of ABBV-155
Timepoint [9] 0 0
Up to approximately 48 days
Secondary outcome [10] 0 0
AUCinf of ABBV-155
Timepoint [10] 0 0
Up to approximately 48 days
Secondary outcome [11] 0 0
QTcF Change from Baseline
Timepoint [11] 0 0
Up to approximately 8 days
Secondary outcome [12] 0 0
t1/2 of ABBV-155
Timepoint [12] 0 0
Up to approximately 48 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center /ID# 241676 - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Israel
State/province [20] 0 0
H_efa
Country [21] 0 0
Israel
State/province [21] 0 0
Tel-Aviv
Country [22] 0 0
Japan
State/province [22] 0 0
Chiba
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Gyeonggido
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul Teugbyeolsi
Country [26] 0 0
Netherlands
State/province [26] 0 0
Noord-Holland
Country [27] 0 0
Netherlands
State/province [27] 0 0
Maastricht
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Utrecht
Country [30] 0 0
Puerto Rico
State/province [30] 0 0
Rio Piedras
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taichung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Tainan
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03595059
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries