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Trial record 1 of 3 for:    ADG126
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ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05405595
Recruitment Status : Recruiting
First Posted : June 6, 2022
Last Update Posted : February 26, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Adagene Inc

Tracking Information
First Submitted Date  ICMJE May 16, 2022
First Posted Date  ICMJE June 6, 2022
Last Update Posted Date February 26, 2024
Actual Study Start Date  ICMJE June 15, 2022
Estimated Primary Completion Date March 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2024)
  • Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab. [ Time Frame: 9 months ]
    Number of participants experiencing maximum tolerated dose (MTD) in dose escalation levels
  • the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors [ Time Frame: 9 months ]
    Number of participants with adverse events as assessed by CTCAE v5.0
  • Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens [ Time Frame: 9 months ]
    Number of Participants with preliminary antitumor activity
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
  • Dose-limiting toxicity (DLT) and RP2D for ADG126 in combination with pembrolizumab. [ Time Frame: 9 months ]
    Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumor
  • the safety and tolerability of ADG126 in combination with pembrolizumab [ Time Frame: 9 months ]
    Number of participants with adverse events as assessed by CTCAE v5.0
  • the maximum tolerated dose (MTD) for ADG126 in combination with pembrolizumab. [ Time Frame: 9 months ]
  • recommended Phase 2 dose (RP2D) of ADG126 in combination with pembrolizumab [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2023)
  • Pharmacokinetic (PK) profile/parameters [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
  • Maximum (peak) plasma concentration (Cmax) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Maximum (peak) plasma concentration (Cmax)
  • Time to maximum (peak) concentration (Tmax) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Time to maximum (peak) concentration (Tmax)
  • Trough concentration (Ctrough) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Trough concentration (Ctrough)
  • Incidence of ADAs [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be summarized for all patients who received at least 1 administration of ADG126. efficacy and safety will be evaluated.
  • To assess the disease control rate (DCR) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be calculated as the proportion/percentage of patients with best overall response of CR,PR,SD or progressive disease will be calculated.
  • To assess the progression free survival (PFS) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    PFS will be censored at the time of the last evaluable tumor assessment (RECISTv1.1 and /or iRECIST)
  • To assess the overall survival (OS) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be used to estimate median survival times where applicable.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
  • Pharmacokinetic (PK) profile/parameters [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
  • Maximum (peak) plasma concentration (Cmax) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Maximum (peak) plasma concentration (Cmax)
  • Time to maximum (peak) concentration (Tmax) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Time to maximum (peak) concentration (Tmax)
  • Trough concentration (Ctrough) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Trough concentration (Ctrough)
  • Incidence of ADAs [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be summarized for all patients who received at least 1 administration of Adg126. efficacy and safety will be evaluated.
  • To assess the disease control rate (DCR) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be calculated as the proportion/percentage of patients with best overall response of CR,PR,SD or progressive disease will be calculated.
  • To assess the progression free survival (PFS) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    PFS will be censored at the time of the last evaluable tumor assessment (RECISTv1.1 and /or iRECIST)
  • To assess the overall survival (OS) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    this will be used to estimate median survival times where applicable.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Official Title  ICMJE A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors
Brief Summary This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
Detailed Description

This is a Phase 1b/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

Study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Solid Tumors
Intervention  ICMJE Drug: ADG126
ADG126 and Pembrolizumab (KEYTRUDA®) combination treatment both will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
Other Name: Pembrolizumab (KEYTRUDA®)
Study Arms  ICMJE Experimental: ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)
An IV infusion of ADG126 over 60-90 minutes will be administered 30-60 minutes after administration of pembrolizumab (KEYTRUDA®) infusion. A treatment cycle will consist of 21 days.
Intervention: Drug: ADG126
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2024)		 131
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2022)		 102
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date March 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥18 years of age at the time of informed consent.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  3. Wash out period from previous antitumor therapies
  4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
  5. Adequate organ function.
  6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.

  7. For Dose Escalation Phase Only: Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists.

    Dose Expansion Phase Only: Tumor tissues (archived or fresh biopsy) before treatment are required for all patients. Biopsies and tumor tissues after treatment are optional but preferred for patients with MSS-CRC and 2L anti-PD-1/anti-PD-L1 experienced NSCLC.

  8. No prior immunotherapy

Exclusion Criteria:

  1. Pregnant or breastfeeding females.
  2. Childbearing potential who does not agree to the use of contraception during the treatment period.
  3. Treatment with any investigational drug within washout period.
  4. Prior treatment with an anti-CTLA-4 therapy.
  5. History of significant immune-mediated AE.
  6. Central nervous system (CNS) disease involvement.
  7. History or risk of autoimmune disease.
  8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
  9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
  10. Major surgery within 4 weeks prior to the first dose of the study drug.
  11. Has had an allogeneic tissue/solid organ transplant.
  12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
  13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaohong She, MS 408-838-9296 kristine_she@adagene.com
Contact: Jiping Zha, MD, PhD 650-785-9347 jiping_zha@adagene.com
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05405595
Other Study ID Numbers  ICMJE ADG126-P001
KEYNOTE-C98, MK-3475-C98 ( Other Identifier: Merck Sharp & Dohme LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Adagene Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Adagene Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Jiping Zha, MD, PhD Adagene Inc
PRS Account Adagene Inc
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP