For Healthcare Professionals

ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors

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About the study

ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion criteria

  1. Adults ≥18 years of age.
  2. ECOG performance status 0 or 1.
  3. Estimated life expectancy of more than 12 weeks .
  4. 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.
  5. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
  6. Adequate organ function.
  7. Meets the additional tumor type requirements as specified in Protocol.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Treatment with any investigational drug within washout period.
  2. Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
  3. History of significant immune-mediated AE.
  4. Central nervous system (CNS) disease involvement.
  5. Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
  6. Clinically significant cardiac disease.
  7. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.

Patients who received:

  1. A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
  2. Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
  3. Known active infection of HBV/BCV/HIV.
  4. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
  5. Second primary malignancy not in remission for greater than 3 years.
  6. History(within the last 5 years) or risk of autoimmune disease.
  7. Pregnant or breastfeeding females.
  8. Childbearing potential who does not agree to the use of contraception during the treatment period.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Advanced/Metastatic Solid Tumors

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

91

Est. Completion Date

Dec 31, 2024

Treatment type

Interventional


Sponsor

Adagene Inc

ClinicalTrials.gov identifier

NCT04645069

Study number

ADG126-1001

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