Docetaxel for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Tumors, Advanced Solid Tumors+1 More
Docetaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the safety and efficacy of ABBV-155 as a monotherapy and in combination with paclitaxel or docetaxel in participants with relapsed or refractory small cell lung cancer, non-small cell lung cancer, and breast cancer.

Eligible Conditions
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Up to approximately 2 to 6 months

Month 12
Duration of Response (DOR)
Number of Participants with Adverse Events (AE)
Progression-Free Survival (PFS)
Month 12
Overall Survival (OS)
Month 6
Overall Response Rate (ORR)
Rate of Complete Response (CR)
Day 21
MTD and/or RPTD of ABBV-155
Day 48
AUCinf of ABBV-155
AUCt of ABBV-155
Cmax of ABBV-155
Terminal Phase Elimination Rate constant of ABBV-155
Tmax of ABBV-155
t1/2 of ABBV-155
Day 8
QTcF Change from Baseline

Trial Safety

Trial Design

5 Treatment Groups

Expansion 2a: ABBV-155 in SCLC
1 of 5
Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer
1 of 5
Expansion 2b: ABBV-155 + docetaxel in NSCLC
1 of 5
Escalation 1b: ABBV-155 + paclitaxel or docetaxel
1 of 5
Escalation 1a: ABBV-155
1 of 5

Experimental Treatment

176 Total Participants · 5 Treatment Groups

Primary Treatment: Docetaxel · No Placebo Group · Phase 1

Expansion 2a: ABBV-155 in SCLC
Drug
Experimental Group · 1 Intervention: ABBV-155 · Intervention Types: Drug
Expansion 2b: ABBV-155 + paclitaxel in Breast CancerExperimental Group · 2 Interventions: ABBV-155, Paclitaxel · Intervention Types: Drug, Drug
Expansion 2b: ABBV-155 + docetaxel in NSCLCExperimental Group · 2 Interventions: Docetaxel, ABBV-155 · Intervention Types: Drug, Drug
Escalation 1b: ABBV-155 + paclitaxel or docetaxelExperimental Group · 3 Interventions: Docetaxel, ABBV-155, Paclitaxel · Intervention Types: Drug, Drug, Drug
Escalation 1a: ABBV-155
Drug
Experimental Group · 1 Intervention: ABBV-155 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 2 to 6 months

Who is running the clinical trial?

AbbVieLead Sponsor
824 Previous Clinical Trials
469,527 Total Patients Enrolled
10 Trials studying Solid Tumors, Advanced Solid Tumors
1,410 Patients Enrolled for Solid Tumors, Advanced Solid Tumors
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
116,973 Total Patients Enrolled
6 Trials studying Solid Tumors, Advanced Solid Tumors
1,156 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologic or cytologic diagnosis of a malignant solid tumor.
Positive HER-2 status should be confirmed based on ASCO/CAP criteria.
You have measurable disease defined by RECIST criteria.
Breast cancer that has progressed after treatment with a CDK4/6 inhibitor.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.