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Closed (no longer recruiting)Last updated: 5 February 2024

This phase I study seeks to understand the safety of a new drug (ADG126) in people with cancers that are advanced and/or have spread to other parts of the body (metastatic)First-in-human (FIH), Open-Label, Phase I Dose Escalation Study of ADG126 in Patients With Advanced Malignancies

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 patients with advanced and/or metastatic cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Adagene Inc

Scientific Title

First-in-human (FIH), Open-Label, Phase I Dose Escalation Study of ADG126 in Patients With Advanced Malignancies

Eligibility

Inclusion

  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

  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.

  8. 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.
  9. Known active infection of HBV/BCV/HIV.
  10. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
  11. Second primary malignancy not in remission for greater than 3 years.
  12. History(within the last 5 years) or risk of autoimmune disease.
  13. Pregnant or breastfeeding females.
  14. 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.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Closed hospitals

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