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Monoclonal Antibodies
ABBV-CLS-484 + PD-1/VEGFR Inhibitors for Cancer
Phase 1
Recruiting
Research Sponsored by Calico Life Sciences LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Must weigh at least 35 kilograms (kg).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (approximately 3 years)
Awards & highlights
Study Summary
This trial is studying the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) in participants with advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried at least one cancer therapy without success. They must be physically capable of daily activities, weigh over 35 kg, and have a life expectancy of at least 12 weeks. Certain conditions like uncontrolled high blood pressure or recent severe illnesses exclude participation.Check my eligibility
What is being tested?
ABBV-CLS-484's safety and effectiveness are being tested alone or with other drugs targeting PD-1 or VEGFR in patients with specific cancers including head and neck squamous cell carcinoma, non-small cell lung cancer, and renal cell carcinoma. The study has three parts: dose escalation for monotherapy and combination therapy, followed by dose expansion.See study design
What are the potential side effects?
Potential side effects may include issues related to the immune system attacking normal cells (autoimmune reactions), problems from drug infusion into the bloodstream (infusion reactions), fatigue, changes in blood pressure, bleeding risks, heart rhythm abnormalities (QT interval changes), as well as liver or kidney function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
I weigh at least 35 kg.
Select...
My cancer is advanced, standard treatments failed, and I've had at least one cancer therapy.
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
Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination therapy)
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-484 (Monotherapy)
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor (Combination therapy)
+14 moreSecondary outcome measures
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 (Monotherapy)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Monotherapy ExpansionExperimental Treatment1 Intervention
ABBV-CLS-484 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), and advanced clear cell renal cell carcinoma (ccRCC)
Group II: Monotherapy Dose EscalationExperimental Treatment1 Intervention
ABBV-CLS-484 will be administered as a monotherapy in subjects with solid tumors
Group III: Combination Expansion with PD-1 InhibitorExperimental Treatment2 Interventions
ABBV-CLS-484 will be administered at the determined recommended dose in combination with Programmed Cell Death-1 Inhibitor in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Group IV: Combination ExpansionExperimental Treatment3 Interventions
ABBV-CLS-484 will be administered at the determined recommended dose in combination with VEGFR TKI in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Group V: Combination Dose Escalation with VEGFR TKIExperimental Treatment2 Interventions
ABBV-CLS-484 will be administered in combination with a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) in subjects with solid tumors
Group VI: Combination Dose Escalation with PD-1 InhibitorExperimental Treatment2 Interventions
ABBV-CLS-484 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
710 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.I currently have an active COVID-19 infection.I do not have ongoing severe numbness or pain in my hands or feet.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for thyroid issues, skin depigmentation, or severe allergies.I have had interstitial lung disease or pneumonitis.I have side effects from cancer treatment that haven't gone away, except for hair loss.I can swallow capsules without issues.I have a history of serious hormone-related health issues that are not under control.I have not had severe side effects from previous immunotherapy.I've had PD-1/PD-L1 therapy and stable or better cancer response, with treatment for specific advanced cancers.I have had serious heart issues or heart failure in the last 6 months.I have had cancer before, but it has been inactive for over 3 years, or it was a non-threatening skin cancer or localized cancer that has been treated.I have had prior PD-1/PD-L1 therapy for my cancer and it either improved, remained stable, or worsened.My liver disease was classified as moderate to severe in the last 6 months.I have had a solid organ or stem cell transplant.I weigh at least 35 kg.I have a history of hepatitis B, C, or HIV.I have not had major surgery in the last 4 weeks.My cancer is advanced, standard treatments failed, and I've had at least one cancer therapy.I have stable brain metastases and don't need steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Expansion
- Group 2: Monotherapy Expansion
- Group 3: Combination Expansion with PD-1 Inhibitor
- Group 4: Combination Dose Escalation with VEGFR TKI
- Group 5: Monotherapy Dose Escalation
- Group 6: Combination Dose Escalation with PD-1 Inhibitor
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.
What objectives are the researchers hoping to accomplish with this investigation?
"This trial has two paramount aims: to attain the Recommended Phase 2 Dose (RP2D) or Maximum Tolerated Dose of ABBV-CLS-484 when administered as monotherapy, and these objectives are evaluated at Baseline up until Approximately Day 42. The secondary targets involve assessing the Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 when employed in conjunction with VEGFR kinase inhibitor and a PD-1 Targeting Agent based on RECIST 1.1 criteria for response evaluation in solid tumors."
Answered by AI
Are any participants being accepted for this research study at present?
"According to current information from clinicaltrials.gov, the recruitment process for this trial is ongoing. First posted on March 9th 2021 and last updated June 29th 2022, the study requires applicants at multiple sites."
Answered by AI
What is the scope of participants for this clinical examination?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial remains open and is actively searching for participants as of June 29th 2022. This research study was posted on March 9th 2021 with a goal of recruiting 248 patients from 5 different locations."
Answered by AI
Is this trial being conducted in multiple sites?
"At present, this study is open to participants at 5 clinics located in San Antonio, New Haven and Providence; plus two other cities. To reduce travelling inconveniences, it is recommended that you select a clinic closest to your residence if you choose to sign up."
Answered by AI
What have been the demonstrated ramifications of administering ABBV-CLS-484 to patients?
"Our team at Power gave ABBV-CLS-484 a score of 1 due to the limited number of studies done to assess its safety and efficacy, as this is classified as an early stage trial."
Answered by AI
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