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

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 Tumours

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).

Trial Description

Primary Outcome:

  • MTD and/or RPTD of ABBV-155
  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of Response (DOR)
  • Rate of Complete Response (CR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Cmax
  • Tmax of ABBV-155
  • Terminal Phase Elimination Rate constant of ABBV-155
  • AUCt
  • AUC∞
  • QTcF Change from Baseline
  • t1/2

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society