ABBV-637 for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms+2 More
ABBV-637 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will evaluate the safety and efficacy of ABBV-637 in participants with solid tumors. ABBV-637 will be given alone or in combination with docetaxel/osimertinib in 28-day cycles.

Eligible Conditions
  • Malignant Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to approximately 3 years

Month 12
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
Month 12
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel (Part 2 & 3)
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Month 20
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel (Part 2 & 3)
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Docetaxel
Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Year 3
Number of Participants Experiencing Adverse Events (AEs)
Percentage of Participants With Objective Response Rate (ORR) (Part 1)
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)

Trial Safety

Trial Design

5 Treatment Groups

Part 2a: ABBV-637 + Docetaxel
1 of 5
Part 3a: ABBV-637 + Osimertinib
1 of 5
Part 2b: ABBV-637 + Docetaxel
1 of 5
Part 1: ABBV-637 Monotherapy
1 of 5
Part 3b: ABBV-637 + Osimertinib
1 of 5

Experimental Treatment

109 Total Participants · 5 Treatment Groups

Primary Treatment: ABBV-637 · No Placebo Group · Phase 1

Part 2a: ABBV-637 + DocetaxelExperimental Group · 2 Interventions: Docetaxel, ABBV-637 · Intervention Types: Drug, Drug
Part 3a: ABBV-637 + OsimertinibExperimental Group · 2 Interventions: Osimertinib, ABBV-637 · Intervention Types: Drug, Drug
Part 2b: ABBV-637 + DocetaxelExperimental Group · 2 Interventions: Docetaxel, ABBV-637 · Intervention Types: Drug, Drug
Part 1: ABBV-637 Monotherapy
Drug
Experimental Group · 1 Intervention: ABBV-637 · Intervention Types: Drug
Part 3b: ABBV-637 + OsimertinibExperimental Group · 2 Interventions: Osimertinib, ABBV-637 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years

Who is running the clinical trial?

AbbVieLead Sponsor
824 Previous Clinical Trials
469,597 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
117,043 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a history of non-small cell lung cancer that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
You have measurable disease per RECIST v1.1.
You have had R/R disease that has progressed on all standard of care therapy.
You have had a history of non-small cell lung cancer that has progressed on osimertinib.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 24th, 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.