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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Combination Dose Expansion, subjects with specific tumor types must have received at least 1 prior line containing PD-1/PD-L1 target therapy as outlined for each tumor type
Histologically or cytologically proven metastatic or locally advanced tumors with measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (approximately 3 years)
Awards & highlights
Study Summary
This trial will help researchers understand if ABBV-CLS-579 is safe and effective when used alone or in combination with other cancer treatments.
Who is the study for?
Adults with certain advanced solid tumors, including specific types of lung cancer (NSCLC), head and neck cancer (HNSCC), and kidney cancer (ccRCC) that have not responded to standard treatments or for which no effective treatment exists. Participants must have tried a PD-1/PD-L1 therapy before, weigh at least 35 kg, have an ECOG performance status ≤2, life expectancy ≥12 weeks, meet laboratory value criteria, and be able to swallow capsules.Check my eligibility
What is being tested?
The trial is testing ABBV-CLS-579 alone and in combination with a PD-1 inhibitor or VEGFR TKI on patients with advanced tumors. It's divided into three parts: dose escalation of ABBV-CLS-579 alone; dose escalation in combination with a PD-1 inhibitor; and expansion using the best dose found along with either a PD-1 inhibitor or VEGFR TKI for specific cancers.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with immunotherapy such as inflammation in various organs, infusion-related reactions like fever or chills during administration of the drug, fatigue from treatment burden, digestive issues due to medication intake method (swallowing pills), blood disorders from changes caused by the drugs' interaction within the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment targeting PD-1/PD-L1 for my cancer type.
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My advanced cancer has no standard treatment left, but I've had at least one cancer treatment before.
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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 weigh at least 35 kilograms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion (approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor
+21 moreSecondary outcome measures
Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1
Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
Change from Baseline QTc
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Monotherapy Dose EscalationExperimental Treatment1 Intervention
ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors
Group II: Combination Expansion with VEGFR TKIExperimental Treatment2 Interventions
ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC.
Group III: Combination Expansion with PD-1Experimental Treatment2 Interventions
ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC)
Group IV: Combination Dose Escalation with PD-1Experimental Treatment2 Interventions
ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
Group V: Backfill Cohorts with MonotherapyExperimental Treatment1 Intervention
ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors
Group VI: Backfill Cohorts in Combination with PD-1Experimental Treatment2 Interventions
ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
Find a Location
Who is running the clinical trial?
Calico Life Sciences LLCLead Sponsor
8 Previous Clinical Trials
695 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,127 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it fits the exceptions.I have had at least one treatment targeting PD-1/PD-L1 for my cancer type.I have a digestive issue that affects my ability to absorb pills or swallow capsules.My advanced cancer has no standard treatment left, but I've had at least one cancer treatment before.I have had bleeding issues, like coughing up blood or bloody stools.I have a history of hepatitis B, C, or HIV.I have not had major surgery in the last 4 weeks.My liver disease was classified as moderate to severe in the last 6 months.I have a hormone disorder that is not well-controlled.I have not had heart failure, heart disease, or serious heart rhythm problems in the last 6 months.I have stable brain metastases and haven't needed steroids for them for at least 28 days.I have not been treated with drugs targeting PD-1/PD-L1 or other immune-boosting agents.My high blood pressure is not well-managed.I can take care of myself and am up and about more than half of my waking hours.I have had interstitial lung disease or pneumonitis.I currently have an active COVID-19 infection.My blood clotting time is within the target range on my current medication.I have side effects from cancer treatment that haven't gone away, except for hair loss.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for thyroid issues, vitiligo, or allergies.I weigh at least 35 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Expansion with VEGFR TKI
- Group 2: Monotherapy Dose Escalation
- Group 3: Backfill Cohorts with Monotherapy
- Group 4: Combination Dose Escalation with PD-1
- Group 5: Backfill Cohorts in Combination with PD-1
- Group 6: Combination Expansion with PD-1
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.
Has the Food and Drug Administration (FDA) sanctioned ABBV-CLS-579 for use?
"The pre-clinical safety assessment provided by our team at Power for ABBV-CLS-579 was a 1 as it is still in its initial testing phase. Therefore, only limited data exists to support efficacy and patient security."
Answered by AI
What is the enrollment capacity of this clinical trial?
"Correct. The data on clinicaltrials.gov suggests that the trial, which was initially published on June 3rd 2020, is still recruiting participants. 263 people are needed to be enrolled from 5 different medical centres."
Answered by AI
What are the key aims of this experiment?
"AbbVie's trial sponsor report reveals that the primary outcome of interest, which will be measured during a period between Baseline and Day 64, is Terminal Phase Elimination Rate Half-Life (t1/2) Of Metabolite M4. Additionally, this research venture shall measure secondary outcomes including Objective Response Rate (ORR) according to RECIST v1.1 criteria on treatment; Best Overall Response (BOR), also based on RECIST v1.1 metrics from start of therapy until disease progression or recurrence; as well as BOR when ABBV-CLS-579 and PD-1 Target"
Answered by AI
Is this research project open to enrollment at the present time?
"Affirmative. Clinicaltrials.gov currently lists the trial as searching for participants, having been initially posted on June 3rd 2020 and last updated on July 8th 2022. 263 patients need to be enrolled from 5 distinct locations in order to reach completion of this research project."
Answered by AI
Are there numerous locations carrying out this scientific examination in the city?
"Five esteemed medical centres are offering this study, such as UPMC Hillman Cancer Center in Pittsburgh, Carolina BioOncology Institute in Huntersville and Yale University in New Haven."
Answered by AI
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