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Monoclonal Antibodies

ABBV-927 + ABBV-181 + Nab-paclitaxel + ABBV-368 + Carboplatin for Solid Tumors

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years since the first dose of study drug
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of ABBV-927, a new cancer treatment, in combination with ABBV-368, Budigalimab, and/or chemotherapy.

Eligible Conditions
  • Solid Tumors
  • Breast Cancer
  • Cancer
  • Metastatic Tumor
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years since the first dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years since the first dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Expansion: Objective Response Rate (ORR)
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181
Secondary outcome measures
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ)
Dose-Expansion Phase: Duration of Response (DOR)
Dose-Expansion Phase: Progression-free Survival (PFS)
+3 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimental Treatment3 Interventions
Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Group II: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBCExperimental Treatment3 Interventions
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Group III: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBCExperimental Treatment2 Interventions
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
Group IV: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBCExperimental Treatment3 Interventions
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Group V: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBCExperimental Treatment3 Interventions
Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Group VI: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimental Treatment3 Interventions
Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
Group VII: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid TumorsExperimental Treatment2 Interventions
Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-181
2013
Completed Phase 1
~500
Nab-paclitaxel
2014
Completed Phase 3
~2030
ABBV-368
2017
Completed Phase 1
~170
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,955 Total Patients Enrolled
7 Trials studying Breast Cancer
454 Patients Enrolled for Breast Cancer
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,789 Total Patients Enrolled

Media Library

ABBV-181 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03893955 — Phase 1
Breast Cancer Research Study Groups: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC, Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors, Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC, Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC, Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC, Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC, Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Breast Cancer Clinical Trial 2023: ABBV-181 Highlights & Side Effects. Trial Name: NCT03893955 — Phase 1
ABBV-181 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03893955 — Phase 1

Frequently Asked Questions

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

Are there any historical accounts of ABBV-927's use in clinical trials?

"ABBV-927 was initially assessed at the City of Hope Comprehensive Cancer Center back in 1997, with a total 1556 studies having been completed since. As of now, there are 1179 active clinical trials concerning this drug; many taking place out of Fort Wayne, Indiana."

Answered by AI

In what geographic areas are the participants of this trial being tested?

"This study is enrolling patients at Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 in Fort Wayne, Indiana; Highlands Oncology Group, PA /ID# 218863 in Santa Rosa, California; and Fort Wayne Medical Oncology /ID# 226072 in Fairfax Virginia as well as 10 additional sites."

Answered by AI

What is the enrollment figure for this research endeavor?

"In order to begin the trial, 150 applicants must meet the selection criteria and be enrolled. AbbVie will manage this project from two sites: Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 in Fort Wayne, Indiana and Highlands Oncology Group, PA /ID# 218863 in Santa Rosa, California."

Answered by AI

Has the FDA sanctioned ABBV-927 for patient usage?

"Our team at Power gave ABBV-927 a safety rating of 1, as the Phase 1 trial offers limited evidence on its efficacy and security."

Answered by AI

To which illnesses has ABBV-927 been most effective in alleviating symptoms?

"ABBV-927 is a commonly prescribed treatment for melanoma, as well as neoplasm metastasis, lymphoma, non-Hodgkin's Lymphoma and advanced Sarcoma."

Answered by AI

What goals is the research team attempting to accomplish with this investigation?

"The primary objective of this trial, which will be observed for up to 6 months, is determining the Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368. Additionally, Secondary outcomes such as Duration Of Response (DOR), Maximum Serum Concentration (Cmax), and Area Under The Curve From Time 0 To Last Measurable Concentration (AUCτ) are also being monitored."

Answered by AI

Are there still openings for applicants in this investigation?

"As indicated on clinicaltrials.gov, recruitment is still ongoing for this trial which was first advertised in May 21st 2019 and most recently updated on November 15th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
2019. "A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03893955.
~26 spots leftby Apr 2025
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