Description:
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).
Title
- Brief Title: A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
- 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 IDs
- ORG STUDY ID:
M16-573
- NCT ID:
NCT03595059
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ABBV-155 | | Escalation 1a: ABBV-155 |
Paclitaxel | | Escalation 1b: ABBV-155 + paclitaxel or docetaxel |
Docetaxel | | Expansion 2b: ABBV-155 + docetaxel in NSCLC |
Purpose
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), subjects 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), subjects will receive ABBV-155 monotherapy or in combination
therapy. The ABBV-155 monotherapy cohort will enroll subjects 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 subjects with R/R non-small cell lung cancer
(NSCLC) and breast cancer (Part 2b).
Trial Arms
Name | Type | Description | Interventions |
---|
Escalation 1a: ABBV-155 | Experimental | Subjects will be administered ABBV-155 (various doses). | |
Escalation 1b: ABBV-155 + paclitaxel or docetaxel | Experimental | Subjects will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel . | - ABBV-155
- Paclitaxel
- Docetaxel
|
Expansion 2a: ABBV-155 in SCLC | Experimental | Description: Subjects with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose). | |
Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer | Experimental | Subjects 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. | |
Expansion 2b: ABBV-155 + docetaxel in NSCLC | Experimental | Subjects 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. | |
Eligibility Criteria
Inclusion Criteria:
- Has a histologic or cytologic diagnosis of a malignant solid tumor.
- Subjects enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung
cancer (SCLC) with tumors that express B7H3 above a given threshold per central
laboratory testing; subjects enrolled to Part 2b (combination therapy, dose expansion)
must have either NSCLC or HR-positive/HER2-negative breast cancer with tumors that
express B7H3 above a given threshold per central laboratory testing.
- 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 subjects in the dose-escalation phase (Parts 1a and 1b).
- All subjects 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 cyclindependent 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 subjects with non-small cell lung cancer (NSCLC) for subjects in the
dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line of
therapy.
- All subjects with SCLC in the dose-expansion phase (Part 2a only) must have R/R SCLC
from 2 lines of therapy which the first line is platinum-based. In addition, 1 of the
2 lines must have included an anti-PD-1/PD-L1.
- All subjects with either breast cancer or NSCLC must have the following: exposure to
prior taxane-based therapy; no history of taxane allergy (Part 1b and Part 2b only);
and 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 (subjects with a history of metastases may be
eligible based on details described in the protocol).
- Grade 2 or higher peripheral neuropathy (only applies to subjects 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.
- For combination therapy only (Parts 1b and 2b), history of serious allergic reaction
to any taxane or any ingredients used in taxane formulation.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | MTD and/or RPTD of ABBV-155 |
Time Frame: | Up to approximately 21 days after initial dose of study drug |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | Up to approximately 12 months |
Safety Issue: | |
Description: | 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. |
Measure: | Rate of Complete Response (CR) |
Time Frame: | Up to approximately 2 to 6 months |
Safety Issue: | |
Description: | CR is defined as the percentage of subjects with documented best response CR according to RECIST version 1.1 |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to approximately 12 months |
Safety Issue: | |
Description: | 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. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 12 months after last dose of study drug |
Safety Issue: | |
Description: | OS is defined as the number of days from the date of first study drug to the date of death due to any cause. |
Measure: | Cmax |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | Maximum plasma concentration (Cmax). |
Measure: | Tmax of ABBV-155 |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | Time to maximum plasma concentration (Tmax). |
Measure: | Terminal Phase Elimination Rate constant of ABBV-155 |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | Terminal phase elimination rate constant of ABBV-155 |
Measure: | AUCt |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt). |
Measure: | AUC∞ |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | AUC from time 0 to infinite time (AUC∞). |
Measure: | QTcF Change from Baseline |
Time Frame: | Up to approximately 8 days |
Safety Issue: | |
Description: | QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy. |
Measure: | t1/2 |
Time Frame: | Up to approximately 48 days |
Safety Issue: | |
Description: | Terminal elimination half-life (t1/2). |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AbbVie |
Trial 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)
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