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

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ClinicalTrials.gov Identifier: NCT04645069
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Adagene Inc

Study Description
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Brief Summary:
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Biological: ADG126 Mono Biological: ADG126-anti PD1 Biological: ADG126-ADG106 Phase 1 Phase 2

Detailed Description:
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: ADG126 mono dose escalation
ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
 Biological: ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
Experimental: ADG126 mono dose expansion
Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
 Biological: ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
Experimental: ADG126-anti PD1 drug dose escalation
Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
 Biological: ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
Experimental: ADG126-anti PD1 drug dose expansion
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
 Biological: ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
Experimental: ADG126-ADG106 dose escalation
Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
 Biological: ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Experimental: ADG126-ADG106 dose expansion
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
 Biological: ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors [ Time Frame: From first dose of ADG126 (Week 1 Day 1) until 21 days ]
  2. Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens [ Time Frame: From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose ]

Secondary Outcome Measures :
  1. Antidrug antibodies (ADAs) [ Time Frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) ]
  2. Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf) [ Time Frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) ]
  3. Maximum (peak) plasma concentration (Cmax) [ Time Frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) ]
  4. Time to maximum (peak) plasma concentration (Tmax) [ Time Frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) ]
  5. Trough plasma concentration (Ctrough) [ Time Frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04645069


Contacts
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Contact: Xiaohong She 4088389296 kristine_she@adagene.com
Contact: Jiping Zha 1-650-785-9347 jiping_zha@adagene.com

Locations
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United States, California
University of California Los Angeles Completed
Los Angeles, California, United States, 90095
United States, Texas
Next oncology Completed
San Antonio, Texas, United States, 78229
Australia, New South Wales
Southside Cancer Care Centre Active, not recruiting
Miranda, New South Wales, Australia, 2228
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia
Contact: JOHN Park         
Australia, Queensland
Sunshine Coast University Private Hospital Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Michelle Morris, Professor         
Australia, Victoria
Cabrini Health Limited Recruiting
Malvern, Victoria, Australia, 3144
Contact: Gary Richardson, Professor         
Australia, Western Australia
One Clinical Research Pty Ltd Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: MIHITHA ARIYAPPERUMA         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: BOON CHER GOH         
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact: YICK CHING JUSTINA LAM         
Sponsors and Collaborators
Adagene Inc
More Information
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Responsible Party: Adagene Inc
ClinicalTrials.gov Identifier: NCT04645069    
Other Study ID Numbers: ADG126-1001
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adagene Inc:
Advanced/Metastatic Solid Tumors
Additional relevant MeSH terms:
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Neoplasms