Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT04111445 |
Recruitment Status :
Terminated
(Study discontinued due to business decision.)
First Posted : October 1, 2019
Last Update Posted : September 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: ADG116 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors |
Actual Study Start Date : | August 29, 2019 |
Actual Primary Completion Date : | April 27, 2021 |
Actual Study Completion Date : | April 27, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: ADG116 |
Drug: ADG116
IV infusion at Day 1 of each cycle |
- Number of participants experiencing dose-limiting toxicities [ Time Frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) ]
- Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Male or female, 18-75 years of age at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study
Exclusion Criteria:
- Pregnant or nursing females.
- Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
- Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
- History of clinically significant cardiac disease.
- Uncontrolled current illness.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111445
United States, Texas | |
NEXT Oncology | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | Adagene Inc |
ClinicalTrials.gov Identifier: | NCT04111445 |
Other Study ID Numbers: |
ADG116-1001 |
First Posted: | October 1, 2019 Key Record Dates |
Last Update Posted: | September 10, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |