Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a non-randomised trial with 5 experimental arms. Each experimental arm involves participants receiving ADG126 (an anti -CTLA-4 fully human monoclonal antibody) intravenously(IV) over a period of 60-90 minutes. Each Experimental Arm receives different dose levels of ADG126. ADG126 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive 4 treatment cycles, administration of ADG126 may continue every 3 weeks for up to 2 years per agreement with investigator and/ or the treating team.
Conditions
This trial is treating people with advanced and/or metastatic cancer
Eligibility
Inclusion
- Adults ≥18 years of age.
- ECOG performance status 0 or 1.
- Estimated life expectancy of more than 12 weeks .
- Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
- Adequate organ function.
- Meets the additional tumor type requirements as specified in Protocol.
Exclusion
- Treatment with any investigational drug within washout period.
- Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
- History of significant immune-mediated AE.
- Central nervous system (CNS) disease involvement.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
- Clinically significant cardiac disease.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
-
Patients who received:
- A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
- Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
- Known active infection of HBV/BCV/HIV.
- Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
- Second primary malignancy not in remission for greater than 3 years.
- History(within the last 5 years) or risk of autoimmune disease.
- Pregnant or breastfeeding females.
- Childbearing potential who does not agree to the use of contraception during the treatment period.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Adagene Inc
Scientific Title
First-in-human (FIH), Open-Label, Phase I Dose Escalation Study of ADG126 in Patients With Advanced Malignancies
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information