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Monoclonal Antibodies
ADG126 Combinations for Advanced Cancer
Phase 1 & 2
Recruiting
Led By Paul De Souza, Professor
Research Sponsored by Adagene Inc
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 from first dose of adg126 (week 1 day 1) to 90 days post last dose
Awards & highlights
Study Summary
This trial is testing the effectiveness of the drug ADG126 on its own and in combination with other drugs to treat patients with advanced solid tumors.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic solid tumors that have worsened after standard treatments, or when no other standard treatments are available. Participants must have at least one measurable tumor and be in relatively good health (ECOG status 0-1) with a life expectancy of more than 12 weeks.Check my eligibility
What is being tested?
The study tests ADG126 alone, combined with an anti-PD1 antibody, and combined with another drug called ADG106. It aims to find out how well these treatments work on patients who have advanced solid tumors that haven't responded to typical therapies.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, as the drugs involve stimulating the immune response against cancer cells. This can sometimes lead to inflammation in various organs, fatigue, possible infection risks, and infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of adg126 (week 1 day 1) to 90 days post last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of adg126 (week 1 day 1) to 90 days post last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Secondary outcome measures
Antidrug antibodies (ADAs)
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Maximum (peak) plasma concentration (Cmax)
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: ADG126-anti PD1 drug dose expansionExperimental Treatment1 Intervention
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
Group II: ADG126-anti PD1 drug dose escalationExperimental Treatment1 Intervention
Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
Group III: ADG126-ADG106 dose expansionExperimental Treatment1 Intervention
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
Group IV: ADG126-ADG106 dose escalationExperimental Treatment1 Intervention
Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
Group V: ADG126 mono dose expansionExperimental Treatment1 Intervention
Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
Group VI: ADG126 mono dose escalationExperimental Treatment1 Intervention
ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
Find a Location
Who is running the clinical trial?
Adagene IncLead Sponsor
10 Previous Clinical Trials
850 Total Patients Enrolled
Paul De Souza, ProfessorPrincipal InvestigatorSouthside Hospital
Gary Richardson, ProfessorPrincipal InvestigatorCabrini Private Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 28 days.I do not have an active HBV, HCV, or HIV infection.I have another cancer that has been in remission for less than 3 years.I am fully active or can carry out light work.I have not had major surgery or serious injury in the last 4 weeks.My cancer has spread to my brain or spinal cord.I have had an organ or bone marrow transplant.I have a serious heart condition.I do not have any ongoing serious infections.I received a COVID-19 vaccine less than a week before starting treatment.I am 18 years old or older.I am not on high doses of steroids or other immune-weakening drugs.I have or am at risk for an autoimmune disease in the last 5 years.My organs are working well.My advanced cancer has not responded to standard treatments, or there are no standard treatments left.
Research Study Groups:
This trial has the following groups:- Group 1: ADG126 mono dose escalation
- Group 2: ADG126 mono dose expansion
- Group 3: ADG126-anti PD1 drug dose escalation
- Group 4: ADG126-anti PD1 drug dose expansion
- Group 5: ADG126-ADG106 dose escalation
- Group 6: ADG126-ADG106 dose 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.
Could you inform me of the overall headcount for those participating in this clinical experiment?
"Affirmative, the clinical trial is still recruiting participants. According to records on clinicaltrials.gov, it was initially posted in March 2021 and revised most recently in May 2022. The study requires 146 people from a single site for enrolment."
Answered by AI
Has ADG126 been accepted by the Food and Drug Administration?
"ADG126 has limited clinical data associated with it, so the safety rating for this medication is 1. This reflects its status in Phase 1 of the trial process."
Answered by AI
Are there open vacancies for participants in this research endeavor?
"Indeed, per records on clinicaltrials.gov this research trial is still open for enrollment. It was first announced on March 15th 2021 and the listing has been modified as recently as May 19th 2022. 146 individuals are needed to participate at 1 locations."
Answered by AI
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