← Back to Search

Monoclonal Antibodies

ADG116 + Immunotherapy for Cancer

Phase 1
Waitlist Available
Research Sponsored by Adagene Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet all of the following inclusion criteria to be eligible for participation in this study: ≥ 18 years of age at the time of informed consent. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks. Estimated life expectancy of more than 12 weeks. For dose escalation, patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented (except patients with HCC, please see below for HCC requirement), who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented. Patients should have at least 1 measurable lesion at baseline according to the definition of RECISTv1.1. Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors or anti programmed cell death protein 1 (PD 1) will also be recruited if they meet all eligibility criteria. Adequate hematologic function, defined by the following: Absolute neutrophil count (ANC) ≥ 1.5 ×109/L, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment. Platelet count ≥ 100 × 109/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment. Patients with HCC and a platelet count ≥75 × 109/L. Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN. Exception: Patients who have serum bilirubin increases due to documented underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia. Adequate renal function defined by either a creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault formula) or serum creatinine (SCr) < 1.5 × ULN Coagulation tests, defined by the following: Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. International normalized ratio (INR) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 × ULN is acceptable for patients on Warfarin anticoagulation. Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram. Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) that has ended at least 4 weeks prior to administration of ADG116. Focal radiation therapy for symptom relief must have been completed at least 2 weeks prior to the first dose of ADG116. Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0 (except for patients with alopecia).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of adg116 (week 1 day 1) to 28 days post last dose
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that could be more effective than current options.

Who is the study for?
Adults over 18 with advanced solid tumors who've exhausted standard treatments or can't access them may join this trial. They should have a life expectancy over 12 weeks, be relatively healthy (ECOG status 0-1), and have at least one measurable tumor lesion. Prior therapies must be completed at least 4 weeks before the study starts, and they shouldn't have severe previous side effects from similar drugs.Check my eligibility
What is being tested?
The trial is testing ADG116, an antibody targeting CTLA-4, which might help the immune system fight cancer. It's also looking at combining ADG116 with either ADG106 or an anti-PD-1 drug to see if these combinations are more effective in treating solid tumors than each drug alone.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions where the body reacts negatively to receiving the drugs intravenously, fatigue, blood disorders like low counts of different types of blood cells that could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of adg116 (week 1 day 1) to 28 days post last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of adg116 (week 1 day 1) to 28 days post last dose for reporting.

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
Secondary outcome measures
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Incidence of ADAs
Maximum (peak) plasma concentration (Cmax)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C : Dose escalation of ADG116 combined with ADG106Experimental Treatment2 Interventions
Group II: Part B : Dose escalation of ADG116 combined with anti PD1 drugExperimental Treatment2 Interventions
Group III: Part A : Dose escalation of ADG116 monotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADG106
2018
Completed Phase 1
~120
ADG116
2022
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Adagene IncLead Sponsor
10 Previous Clinical Trials
869 Total Patients Enrolled

Media Library

ADG116 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04501276 — Phase 1
Solid Tumors Clinical Trial 2023: ADG116 Highlights & Side Effects. Trial Name: NCT04501276 — Phase 1
ADG116 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04501276 — Phase 1
Solid Tumors Research Study Groups: Part C : Dose escalation of ADG116 combined with ADG106, Part B : Dose escalation of ADG116 combined with anti PD1 drug, Part A : Dose escalation of ADG116 monotherapy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ADG116 obtained clearance from the Food and Drug Administration?

"ADG116's safety profile is rated 1, as it has not yet been subject to extensive clinical trials. Consequently, the available data regarding efficacy and safety are limited."

Answered by AI

How many research participants have been enlisted to participate in this project?

"Affirmative. Clinicaltrials.gov indicates that this medical trial, which was initially advertised on 23rd September 2020, is actively recruiting individuals for the study. 204 patients must be sourced from a single site to complete the research project."

Answered by AI

Is this experiment currently open to recruitment?

"Correct. According to clinicaltrials.gov, this trial is seeking participants and was initially posted on September 23rd 2020 before its most recent update on January 26th 2022. The research requires 204 volunteers from 1 medical site."

Answered by AI
Recent research and studies
~5 spots leftby Jul 2024