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Monoclonal Antibodies

ABBV-637 + Chemotherapy for Cancer

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic solid tumor diagnosis (Part 1)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Must not have
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
Adults with relapsed/refractory solid tumors, specifically non-small cell lung cancer (NSCLC), who have tried all standard treatments can join. They must be in good physical condition (ECOG 0 or 1) and meet specific lab values. For certain parts of the study, participants need to have a history of NSCLC that has worsened after specific previous treatments.
What is being tested?
The trial is testing ABBV-637 alone or combined with Docetaxel/Osimertinib for safety and effectiveness against NSCLC. It's divided into three parts: first tests ABBV-637 solo, then its combination with Docetaxel, and finally with Osimertinib. Participants will receive cycles of treatment over approximately 28 days.
What are the potential side effects?
Potential side effects include reactions related to IV administration of drugs, possible organ inflammation due to immune responses, fatigue from treatment burden, digestive issues from medication interactions, blood-related complications from chemotherapy agents like Docetaxel and risks associated with daily oral tablets such as Osimertinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a solid tumor.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have side effects from cancer treatment that have not gone away, except for hair loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Adverse Events (AEs)
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
Secondary study objectives
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 3b: ABBV-637 + OsimertinibExperimental Treatment2 Interventions
Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.
Group II: Part 3a: ABBV-637 + OsimertinibExperimental Treatment2 Interventions
Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
Group III: Part 2b: ABBV-637 + DocetaxelExperimental Treatment2 Interventions
Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
Group IV: Part 2a: ABBV-637 + DocetaxelExperimental Treatment2 Interventions
Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
Group V: Part 1: ABBV-637 MonotherapyExperimental Treatment1 Intervention
Participants will receive escalating doses of ABBV-637 in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1120
Docetaxel
1995
Completed Phase 4
~6550

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,498 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,283 Total Patients Enrolled

Media Library

ABBV-637 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04721015 — Phase 1
Cancer Research Study Groups: Part 3a: ABBV-637 + Osimertinib, Part 3b: ABBV-637 + Osimertinib, Part 1: ABBV-637 Monotherapy, Part 2a: ABBV-637 + Docetaxel, Part 2b: ABBV-637 + Docetaxel
Cancer Clinical Trial 2023: ABBV-637 Highlights & Side Effects. Trial Name: NCT04721015 — Phase 1
ABBV-637 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721015 — Phase 1
~3 spots leftby Feb 2025
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