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Monoclonal Antibodies
ABBV-706 + Chemotherapy for Advanced Solid Cancers
Phase 1
Recruiting
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
Awards & highlights
Study Summary
This trial is testing ABBV-706, an investigational drug, as a potential treatment for small cell lung cancer, high-grade central nervous system tumors and high-grade neuroendocrine carcinomas. 350 adults are being enrolled at sites worldwide.
Who is the study for?
Adults with advanced solid tumors, including specific types of lung cancer and high-grade brain or neuroendocrine cancers that have worsened despite standard treatments. Participants must be in good physical condition (ECOG 0-1), have acceptable heart function, and measurable disease. Those with certain lung conditions or previous treatment with similar drugs are excluded.Check my eligibility
What is being tested?
The trial is testing ABBV-706 alone or combined with budigalimab, carboplatin, or cisplatin for treating various advanced cancers. It involves escalating doses to find the maximum tolerated dose and then further study at selected doses to assess safety and preliminary effectiveness.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, organ inflammation like pneumonitis (lung issues), fatigue, blood abnormalities, digestive problems, increased risk of infections due to immune system effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antidrug Antibodies (ADAs)
Plasma
Duration of response (DOR) for Participants with Confirmed CR/PR
+11 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part 4b: ABBV-706 Monotherapy Dose Expansion NECsExperimental Treatment1 Intervention
Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 1 year treatment period.
Group II: Part 4a: ABBV-706 Monotherapy Dose Expansion CNS TumorsExperimental Treatment1 Intervention
Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 1 year treatment period.
Group III: Part 3b: ABBV-706 + Platinum ChemotherapyExperimental Treatment3 Interventions
Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.
Group IV: Part 3a: ABBV-706 + BudigalimabExperimental Treatment2 Interventions
Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.
Group V: Part 2: ABBV-706 Monotherapy Dose Optimization and ExpansionExperimental Treatment1 Intervention
Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 1 year treatment period..
Group VI: Part 1: ABBV-706 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Budigalimab
2021
Completed Phase 1
~170
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
956 Previous Clinical Trials
501,000 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
395 Previous Clinical Trials
145,714 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My small cell lung cancer has worsened after initial platinum-based treatment.I have previously been treated with a SEZ6-targeted antibody drug.I have never needed steroids for lung inflammation.My brain tumor has grown or returned, confirmed by MRI or biopsy, after recent radiation therapy.I have been treated with a specific type of targeted therapy before.I have had idiopathic pulmonary fibrosis or organizing pneumonia.My small cell lung cancer has returned or didn't respond after platinum-based treatment.I have small cell lung cancer or certain neuroendocrine cancers that have returned after platinum-based chemotherapy.I can provide a recent or older sample of my tumor for analysis.I have an advanced cancer with no cure left and it may express SEZ6.My cancer has spread to my brain from another part of my body.I am fully active or can carry out light work.I have a high-grade brain tumor with no cure left after standard treatment.My cancer can be measured using specific criteria.I have a type of advanced neuroendocrine tumor and standard treatments haven't worked.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
- Group 2: Part 1: ABBV-706 Monotherapy Dose Escalation
- Group 3: Part 3a: ABBV-706 + Budigalimab
- Group 4: Part 3b: ABBV-706 + Platinum Chemotherapy
- Group 5: Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
- Group 6: Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to new participants?
"Data from clinicaltrials.gov suggests that this medical trial is open to new participants, with the study first being posted on December 5th 2022 and amended as recently as December 13th 2022."
Answered by AI
What risks can be associated with administering Part 3b: ABBV-706 + Platinum Chemotherapy to individuals?
"Our team at Power judged the safety of Part 3b: ABBV-706 + Platinum Chemotherapy to be a 1, since it is in its early phase and limited data exists regarding both efficacy and safety."
Answered by AI
Are there multiple medical facilities conducting this research within state boundaries?
"For this experiment, 4 medical centres are currently recruiting patients. These facilities are located in San Antonio, Grand Rapids, Oklahoma City and additional sites can be found nearby to reduce commute time for those that decide to participate."
Answered by AI
How many individuals are being included in this experiment?
"Affirmative. Clinicaltrials.gov verifies that this research effort, which was inaugurated on December 5th 2021, is currently seeking participants. The investigators are attempting to recruit 350 volunteers from 4 distinct medical facilities."
Answered by AI
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