Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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).

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

Keywords

Advanced Solid Tumors Cancer Relapsed and/or Refractory Solid Tumors ABBV-155 Taxane Paclitaxel Docetaxel breast cancer non-small cell lung cancer (NSCLC) small cell lung cancer (SCLC) Neoplasms Albumin-Bound Paclitaxel Escalation 1a: ABBV-155 Expansion 2a: ABBV-155 in SCLC Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer Expansion 2b: ABBV-155 + docetaxel in NSCLC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Moores Cancer Center - LaJolla /ID# 201570 not yet accepting patients
    La Jolla California 92093 United States
  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105 not yet accepting patients
    Orange California 92868-3201 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03595059
Phase
Phase 1
Study Type
Interventional
Last Updated