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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Drug: ADG126 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 131 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : March 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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®)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens [ Time Frame: 9 months ]
    Number of Participants with preliminary antitumor activity


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. Trough concentration (Ctrough) [ Time Frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years) ]
    Trough concentration (Ctrough)

  5. 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.

  6. 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.

  7. 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)

  8. 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.


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. ≥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.
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): NCT05405595


Contacts
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Contact: Xiaohong She, MS 408-838-9296 kristine_she@adagene.com
Contact: Jiping Zha, MD, PhD 650-785-9347 jiping_zha@adagene.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Sharma Sunil, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Daneng Li, MD         
United States, Florida
Florida cancer specialist Recruiting
Sarasota, Florida, United States, 34232
Contact: Patel Manish, MD         
Contact: Rami Guy         
Korea, Republic of
Dong -A University Hospital Recruiting
Seogu, Busan Gwangyeogsi, Korea, Republic of, 49201
Contact: Sung Yong Oh, MD         
Contact: Grami Dong         
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbugdo, Korea, Republic of, 28644
Contact: Ki Hyeong Lee, MD         
Contact: Seul gi Gong         
CHA Bundang Medical Center, CHA university Recruiting
Seongnam, Gyeonggido, Korea, Republic of, 13496
Contact: Hing Jae Chon, MD         
Contact: Song I Kang         
The Catholic University of Korea Street. Vincent Hospital Recruiting
Suwon, Gyeonggido, Korea, Republic of, 16247
Contact: Yun Gyoo Lee, MD         
Samsung Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Contact: Byoung Yong Shim, MD         
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 41931
Contact: Keon Uk Park, MD         
Contact: Ehyun Choi         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Seock -Ah Im, MD         
Contact: Kim Ji Won         
KangBuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 03081
Contact: Yun Gyoo Lee, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Sun Young Kim, MD         
Contact: Ko Eun- Young         
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 3722
Contact: Sang Joon Shin, MD         
Contact: Da Seul Lee         
Sponsors and Collaborators
Adagene Inc
Merck Sharp & Dohme LLC
Investigators
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Study Director: Jiping Zha, MD, PhD Adagene Inc
More Information
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Responsible Party: Adagene Inc
ClinicalTrials.gov Identifier: NCT05405595    
Other Study ID Numbers: ADG126-P001
KEYNOTE-C98, MK-3475-C98 ( Other Identifier: Merck Sharp & Dohme LLC )
First Posted: June 6, 2022    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action