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ABBV-155 + Taxanes for Solid Cancers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have been diagnosed with a solid tumor cancer.My blood, liver, and kidney tests meet the study's requirements.My NSCLC has returned or resisted treatment, and I've had targeted therapy if I have specific gene mutations.I have side effects from cancer treatment that haven't gone away, except for hair loss.I do not have an active hepatitis B, C, or HIV infection, or I meet the study's exception criteria.I have small cell lung cancer that has returned or didn't respond to treatment including platinum-based therapy.I am a breast cancer patient in the dose-expansion phase.My breast cancer is advanced, HR-positive/HER2-negative and didn't respond to CDK4/6 inhibitor therapy.My cancer is HR-positive and HER2-negative according to specific medical standards.I can take care of myself and am up and about more than half of my waking hours.I have SCLC for monotherapy or NSCLC/HR-positive/HER2-negative breast cancer for combination therapy.My condition worsened 2 months after my last taxane-based treatment.I have had taxane-based therapy for my breast or lung cancer.I do not have severe numbness, pain, or weakness in my hands or feet.I have not had serious heart issues in the last 6 months.I have tried at least one chemotherapy treatment without success.I have brain or meningeal metastases that haven't been treated.I am not allergic to ABBV-155 or any taxane ingredients.
- Group 1: Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer
- Group 2: Expansion 2b: ABBV-155 + docetaxel in NSCLC
- Group 3: Expansion 2a: ABBV-155 in SCLC
- Group 4: Escalation 1b: ABBV-155 + paclitaxel or docetaxel
- Group 5: Escalation 1a: ABBV-155
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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