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NCT03595059 · ClinicalTrials.gov registry record · Phase 1
A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
NCT03595059: Completed Phase 1 study, sponsored by AbbVie.
NCT03595059 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 168 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03595059, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
Study 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).
Primary Outcome
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).
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG ABBV-155
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 1 |
What the finished NCT03595059 record still lists
NCT03595059 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT03595059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03595059 about?
NCT03595059 is a clinical study titled "A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors". 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 monothe...
What is the current status of trial NCT03595059?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2018-07-13. Estimated completion is 2025-09-12.
What interventions are being tested in trial NCT03595059?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), ABBV-155 (DRUG).
Who is sponsoring clinical trial NCT03595059?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03595059's enrollment target sits among peer trials
168 326th of 2000 higher than 1,671 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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