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Monoclonal Antibodies
AB248 + Pembrolizumab for Cancer
Phase 1
Recruiting
Research Sponsored by Asher Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale
Age ≥18 years of age at the time consent is signed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 up to 90 days after discontinuing study treatment
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe & effective for treating advanced or metastatic solid tumors. It will evaluate safety, how the body absorbs it, & preliminary effectiveness.
Who is the study for?
Adults over 18 with advanced or metastatic solid tumors, including specific cancers like lung and kidney cancer. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and not have had recent cancer treatments or other anticancer therapies while on the study. They can't join if they have active infections, autoimmune diseases, a history of severe allergies to similar drugs, or are taking immunosuppressants.Check my eligibility
What is being tested?
The trial is testing AB248 alone or combined with Pembrolizumab for safety and effectiveness against various advanced solid tumors. It's an early-stage trial that includes increasing doses to find safe levels followed by further testing at those levels.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system due to Pembrolizumab such as inflammation in organs, fatigue, skin issues, flu-like symptoms and potential infusion-related reactions; specifics for AB248 aren't listed but could be similar.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
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My cancer is advanced or has spread and cannot be cured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 1 up to 90 days after discontinuing study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 up to 90 days after discontinuing study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death
Frequency of Adverse Events of Special Interest (AESIs)
Frequency of Dose-Limiting Toxicities (DLTs)
+2 moreSecondary outcome measures
AUC Area under the Plasma Concentration versus Time Curve (AUC) of AB248
Changes in CD8+ T cell density in tumor tissues
Disease Control Rate (DCR) according to RECIST version 1.1
+8 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: AB248 Monotherapy Indication ExpansionExperimental Treatment1 Intervention
AB248 will be administered intravenously as a single agent in disease specific cohorts
Group II: AB248 Monotherapy Dose-EscalationExperimental Treatment1 Intervention
AB248 will be administered intravenously as a single agent
Group III: AB248 + Pembrolizumab Combination Indication ExpansionExperimental Treatment2 Interventions
AB248 and pembrolizumab will be administered intravenously in disease specific cohorts
Group IV: AB248 + Pembrolizumab Combination Dose-EscalationExperimental Treatment2 Interventions
AB248 and pembrolizumab will be administered intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Asher Biotherapeutics, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,409 Total Patients Enrolled
Medical MonitorStudy DirectorAsher Biotherapeutics, Inc.
1,660 Previous Clinical Trials
983,567 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have an autoimmune disease that is not controlled.Your disease can be measured using specific guidelines by the local doctor or radiologist.My organs are functioning well according to recent tests.I am currently being treated for an infection.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I haven't taken steroids or immunosuppressants in the last 7 days.I have been treated with drugs targeting IL-2, IL-7, or IL-15 before.I've had a severe allergic reaction to pembrolizumab or similar drugs.I have been diagnosed with an immune system disorder.I had cancer before, but it's been treated and I've been cancer-free for 5 years.I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.I am 18 years old or older.My cancer has spread to my brain or its coverings.My cancer is advanced or has spread and cannot be cured.I will not need any cancer treatment other than the study's while participating.
Research Study Groups:
This trial has the following groups:- Group 1: AB248 Monotherapy Dose-Escalation
- Group 2: AB248 + Pembrolizumab Combination Dose-Escalation
- Group 3: AB248 Monotherapy Indication Expansion
- Group 4: AB248 + Pembrolizumab Combination Indication Expansion
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 recruitment currently open for this trial?
"Clinicaltrials.gov states that this research study is not presently recruiting participants, even though the trial was first listed on December 1st 2022 and underwent a recent edit on December 8th 2022. Despite this, there are 4273 other medical trials still actively seeking out volunteers."
Answered by AI
Has the AB248 + Pembrolizumab Combination Dose-Escalation protocol attained regulatory approval?
"Because of the limited amount of data regarding safety and efficacy, AB248 + Pembrolizumab Combination Dose-Escalation has been rated a 1 on our team's scale."
Answered by AI
What results is this investigation attempting to attain?
"This trial aims to ascertain the frequency of Serious Adverse Events (SAEs) from Study Day 1 up until 90 days post-treatment discontinuation. Other objectives include quantifying CD8+ T cell levels in peripheral blood via flow cytometry, assessing Disease Control Rate (DCR) according to RECIST version 1.1 standards, and determining Frequency of anti-drug antibodies (ADA)s related AB248 immunogenicity throughout treatment and 30 days following its completion."
Answered by AI
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