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

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ClinicalTrials.gov Identifier: NCT03595059
Recruitment Status : Suspended (Safety)
First Posted : July 23, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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), 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).


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: ABBV-155 Drug: Paclitaxel Drug: Docetaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escalation 1a: ABBV-155
Subjects will be administered ABBV-155 (various doses).
Drug: ABBV-155
intravenous

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

Drug: Paclitaxel
intravenous

Drug: Docetaxel
intravenous

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

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

Drug: Paclitaxel
intravenous

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

Drug: Docetaxel
intravenous




Primary Outcome Measures :
  1. MTD and/or RPTD of ABBV-155 [ Time Frame: Up to approximately 21 days after initial dose of study drug ]
    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).

  2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 to 6 months ]
    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.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to approximately 12 months ]
    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.

  2. Rate of Complete Response (CR) [ Time Frame: Up to approximately 2 to 6 months ]
    CR is defined as the percentage of subjects with documented best response CR according to RECIST version 1.1

  3. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 12 months ]
    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.

  4. Overall Survival (OS) [ Time Frame: Up to approximately 12 months after last dose of study drug ]
    OS is defined as the number of days from the date of first study drug to the date of death due to any cause.

  5. Cmax [ Time Frame: Up to approximately 48 days ]
    Maximum plasma concentration (Cmax).

  6. Tmax of ABBV-155 [ Time Frame: Up to approximately 48 days ]
    Time to maximum plasma concentration (Tmax).

  7. Terminal Phase Elimination Rate constant of ABBV-155 [ Time Frame: Up to approximately 48 days ]
    Terminal phase elimination rate constant of ABBV-155

  8. AUCt [ Time Frame: Up to approximately 48 days ]
    Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).

  9. AUC∞ [ Time Frame: Up to approximately 48 days ]
    AUC from time 0 to infinite time (AUC∞).

  10. QTcF Change from Baseline [ Time Frame: Up to approximately 8 days ]
    QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.

  11. t1/2 [ Time Frame: Up to approximately 48 days ]
    Terminal elimination half-life (t1/2).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histologic or cytologic diagnosis of a malignant solid tumor.
  • 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.
  • All subjects with either breast cancer or non-small cell lung cancer (NSCLC) must have the following: exposure to prior taxane-based therapy; no history of taxane allergy (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.
  • 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 breast cancer with tumors that express B7H3 above a given threshold per central laboratory testing.

Exclusion Criteria:

  • History of severe osteoporosis with previous spontaneous fractures.
  • 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595059


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Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03595059     History of Changes
Other Study ID Numbers: M16-573
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
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)

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Docetaxel
Taxane
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action