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Monoclonal Antibodies

ABBV-155 + Taxanes for Solid Cancers

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
Has a histologic or cytologic diagnosis of a malignant solid tumor.
Adequate kidney, liver, and hematologic laboratory values as described in the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 to 6 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with solid tumors that have come back or didn't respond to treatment. It's open to those with specific types of lung and breast cancer, who've tried certain therapies without success. Participants need good organ function, no severe allergies to the drugs being tested, and must not have had serious heart issues or untreated brain metastases recently.Check my eligibility
What is being tested?
The study tests ABBV-155 alone and combined with taxanes (paclitaxel or docetaxel) in two parts: dose escalation to find safe levels, followed by dose expansion focusing on small cell lung cancer (SCLC) for monotherapy and non-small cell lung cancer (NSCLC)/breast cancer for combination therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to ABBV-155, issues from taxane therapy like nerve damage (neuropathy), as well as common chemotherapy-related effects such as fatigue, digestive problems, blood disorders, and increased risk of infections.

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 cancer.
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My blood, liver, and kidney tests meet the study's requirements.
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My NSCLC has returned or resisted treatment, and I've had targeted therapy if I have specific gene mutations.
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I have small cell lung cancer that has returned or didn't respond to treatment including platinum-based therapy.
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I am a breast cancer patient in the dose-expansion phase.
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My breast cancer is advanced, HR-positive/HER2-negative and didn't respond to CDK4/6 inhibitor therapy.
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My cancer is HR-positive and HER2-negative according to specific medical standards.
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I can take care of myself and am up and about more than half of my waking hours.
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I have SCLC for monotherapy or NSCLC/HR-positive/HER2-negative breast cancer for combination therapy.
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My condition worsened 2 months after my last taxane-based treatment.
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I have had taxane-based therapy for my breast or lung cancer.
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I have tried at least one chemotherapy treatment without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD and/or RPTD of ABBV-155
Overall Response Rate (ORR)
Secondary outcome measures
AUCinf of ABBV-155
AUCt of ABBV-155
Cmax of ABBV-155
+9 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Expansion 2b: ABBV-155 + paclitaxel in Breast CancerExperimental Treatment2 Interventions
Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.
Group II: Expansion 2b: ABBV-155 + docetaxel in NSCLCExperimental Treatment2 Interventions
Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.
Group III: Expansion 2a: ABBV-155 in SCLCExperimental Treatment1 Intervention
Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
Group IV: Escalation 1b: ABBV-155 + paclitaxel or docetaxelExperimental Treatment3 Interventions
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Group V: Escalation 1a: ABBV-155Experimental Treatment1 Intervention
Participants will be administered ABBV-155 (various doses).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
496,234 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,987 Total Patients Enrolled

Media Library

ABBV-155 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03595059 — Phase 1
Solid Tumors Research Study Groups: Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer, Expansion 2b: ABBV-155 + docetaxel in NSCLC, Expansion 2a: ABBV-155 in SCLC, Escalation 1b: ABBV-155 + paclitaxel or docetaxel, Escalation 1a: ABBV-155
ABBV-155 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03595059 — Phase 1
Solid Tumors Clinical Trial 2023: ABBV-155 Highlights & Side Effects. Trial Name: NCT03595059 — Phase 1

Frequently Asked Questions

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

In what contexts is Docetaxel usually prescribed?

"Docetaxel is a frequently prescribed medication for neoplasm metastasis, and can also aid those suffering from soft tissue sarcoma (STS), locally advanced non-small cell lung cancer, and metastatic bladder cancer."

Answered by AI

What is the purpose of this experiment?

"The primary measure of efficacy for this trial, assessed over a 21-day period after the first dose is Overall Response Rate (ORR). Secondary outcomes evaluated are QTcF Change from Baseline, Complete Response Rate, and Cmax of ABBV-155."

Answered by AI

Is there still an opportunity for individuals to enroll in this experiment?

"According to the information published on clinicaltrials.gov, this trial is currently enrolling participants. The research project was launched on July 13th 2018 and its last edit occured 11 months later in November 2022."

Answered by AI

Has the Food and Drug Administration granted permission for Docetaxel to be used medicinally?

"Because there is scant evidence for safety and efficacy, Docetaxel receives a low score of 1 on our team's risk assessment scale."

Answered by AI

Could you please provide an overview of the other experiments that have utilized Docetaxel?

"Currently, 1088 clinical trials are being conducted to assess the efficacy of Docetaxel worldwide. Of these studies, 317 are in Phase 3 and there is a total 58781 different locations involved in this research effort. Shanghai has a notably high concentration of such investigations with multiple sites running experiments for this treatment."

Answered by AI

What is the upper limit for participants in this trial?

"AbbVie, the sponsor of this trial, requires 176 patients that meet their specific inclusion criteria to participate. The locations hosting these trials include Highlands Oncology Group in Springdale, Arkansas and Vanderbilt Ingram Cancer Center located in Nashville Tennessee."

Answered by AI

How many test sites have been established for this experiment?

"Highlands Oncology Group in Springdale, Arkansas (ID# 201568), Vanderbilt Ingram Cancer Center in Nashville, Tennessee (ID# 201575) and Highlands Oncology Group in Providence Rhode island (ID#201568) are all sites recruiting patients for this study. Additionally there are 24 other locations taking part."

Answered by AI
~0 spots leftby Mar 2024