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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Adverse Events (AEs)
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
Secondary outcome measures
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

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
~1010
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,963 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,797 Total Patients Enrolled

Media Library

ABBV-637 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04721015 — Phase 1
Cancer Research Study Groups: Part 3b: ABBV-637 + Osimertinib, Part 3a: 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this experiment?

"AbbVie, the study sponsor, requires 109 eligible participants to carry out this trial. The two sites participating in the experiment are UH Cleveland Medical Center (ID# 225504) located in Ohio and Lifespan Cancer Institute at Rhode island Hospital (ID# 226145), which is based in Providence."

Answered by AI

Is this research recruitment still underway?

"According to info from clinicaltrials.gov, this medical study is currently ongoing and accepting participants. The trial was initially advertised on February 23rd 2021 and the most recent amendment was made September 12th 2022."

Answered by AI

What impact does ABBV-637 have on human health?

"Due to a lack of evidence, our team at Power assigned ABBV-637 the rating of 1 on their safety scale. This is because it's only in phase one trials, where there has been minimal data collected regarding efficacy and security."

Answered by AI

Are there any precedents of trials involving ABBV-637?

"Currently, there are 419 trials analyzing ABBV-637 with 143 of them in their final phase. Although many studies for this drug are conducted in Natal, Rio Grande Do Norte, the global participation rate has resulted in 27026 locations around the world running clinical trials on it."

Answered by AI

How many medical centers are actively executing this trial?

"Currently, 9 different medical centres are involved in this study: UH Cleveland Medical Center (ID# 225504), Lifespan Cancer Institute at Rhode island Hospital (ID# 226145) and South Texas Accelerated Research Therapeutics (ID# 225359) amongst other facilities."

Answered by AI

To what medical issues is ABBV-637 primarily applied?

"ABBV-637 has been found to be useful in managing metastatic bladder cancer, neoplasm metastasis and advance directives."

Answered by AI

What are the essential goals of this clinical trial?

"The principal purpose of this 3-year long trial is to quantify the number of participants that experience adverse effects. Additionally, secondary goals are centered around overall survival (time from first dose until death), duration response for ABBV-637 in combination with docetaxel and osimertinib (time from initial response to radiographic or clinical disease progression or death)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
2021. "Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04721015.
~19 spots leftby Apr 2025
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