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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.
Locally advanced or metastatic HR-positive/HER2-negative breast cancer after failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.
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.
Select...
My breast cancer is advanced, HR-positive/HER2-negative and didn't respond to CDK4/6 inhibitor therapy.
Select...
My cancer is HR-positive and HER2-negative according to specific medical standards.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have had taxane-based therapy for my breast or lung cancer.
Select...
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
971 Previous Clinical Trials
504,959 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
406 Previous Clinical Trials
148,848 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
~15 spots leftby Dec 2024
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