Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-29 @ 7:06 AM
Study NCT ID:
NCT05405595
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2022-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D014271', 'term': 'Trifluridine'}, {'id': 'C000613803', 'term': 'trifluridine tipiracil drug combination'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C000591844', 'term': 'HMPL-013'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab.', 'timeFrame': '9 months', 'description': 'Number of participants experiencing maximum tolerated dose (MTD) in dose escalation levels'}, {'measure': 'the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors', 'timeFrame': '9 months', 'description': 'Number of participants with adverse events as assessed by CTCAE v5.0'}, {'measure': 'Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens', 'timeFrame': '9 months', 'description': 'Number of Participants with preliminary antitumor activity'}, {'measure': 'Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab', 'timeFrame': '6 months', 'description': 'To assess the safety and tolerability of ADG126 + pembrolizumab in combination with the following SOC therapies (Trifluridine/tipiracil-bevacizumab) in MSS CRC\n\nTo determine the MTD and/or RP2D for ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC:'}, {'measure': 'Access the preliminary antitumor activity of ADG126 with Pembrolizumab in combination standard of care', 'timeFrame': '6 months', 'description': 'To assess the preliminary antitumor activity of ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC (Trifluridine/tipiracil-bevacizumab)\n\nSOC (Fruquintinib)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile/parameters', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)'}, {'measure': 'Maximum (peak) plasma concentration (Cmax)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'Maximum (peak) plasma concentration (Cmax)'}, {'measure': 'Time to maximum (peak) concentration (Tmax)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'Time to maximum (peak) concentration (Tmax)'}, {'measure': 'Trough concentration (Ctrough)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'Trough concentration (Ctrough)'}, {'measure': 'Incidence of ADAs', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'this will be summarized for all patients who received at least 1 administration of ADG126. efficacy and safety will be evaluated.'}, {'measure': 'To assess the disease control rate (DCR)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'this will be calculated as the proportion/percentage of patients with best overall response of CR,PR,SD or progressive disease will be calculated.'}, {'measure': 'To assess the progression free survival (PFS)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'PFS will be censored at the time of the last evaluable tumor assessment (RECISTv1.1 and iRECIST)'}, {'measure': 'To assess the overall survival (OS)', 'timeFrame': 'From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)', 'description': 'this will be used to estimate median survival times where applicable.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADG126-P001'], 'conditions': ['Advanced/Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 alone or ADG126-Pembrolizumab in combination with trifluridine/tipiracil-bevacizumab or fruquintinib in patients with advanced/metastatic solid tumors, with a focus on MSS CRC.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years of age at the time of informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. Wash out period from previous antitumor therapies\n4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.\n5. Adequate organ function.\n6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.\n7. For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.\n8. Dose Expansion Phase Only: Tumor tissues (archived or fresh biopsy) before treatment are required for all patients.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females.\n2. Childbearing potential who does not agree to the use of contraception during the treatment period.\n3. Treatment with any investigational drug within washout period.\n4. Prior treatment with an anti-CTLA-4 therapy.\n5. History of significant irAEs or irAE.\n6. Central nervous system (CNS) disease involvement.\n7. History or risk of autoimmune disease.\n8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\\>10 mg/day prednisone or equivalent).\n9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).\n10. Major surgery within 4 weeks prior to the first dose of the study drug.\n11. Has had an allogeneic tissue/solid organ transplant.\n12. 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.\n13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.\n14. History of severe Hypersensitivity (Grade ≥3)or known to be allergic to protein drugs or recombinant protein.'}, 'identificationModule': {'nctId': 'NCT05405595', 'briefTitle': 'ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adagene Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ADG126-P001'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-C98, MK-3475-C98', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)', 'description': '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. ADG126 and Pembrolizumab (KEYTRUDA®) combination treatment both will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.', 'interventionNames': ['Drug: ADG126', 'Drug: Pembrolizumab (KEYTRUDA®)']}, {'type': 'EXPERIMENTAL', 'label': 'ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab', 'description': 'To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Trifluridine/Tipiracil-Bevacizumab) while assessing safety and tolerability. Standard of care treatment will be administered according to the specifications outlined in the Investigational Brochure. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.', 'interventionNames': ['Drug: ADG126', 'Drug: Pembrolizumab (KEYTRUDA®)', 'Drug: Standard of Care (Trifluridine/Tipiracil-Bevacizumab)']}, {'type': 'EXPERIMENTAL', 'label': 'ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib', 'description': 'To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Fruquintinib) while assessing safety and tolerability. The dose strength for treatment will be based on the IB and protocol. Fruquintinib (Fruzaqla) is orally given once daily for the first 21 days of each 28-day cycle. Each treatment cycle consists of 14 days. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.', 'interventionNames': ['Drug: ADG126', 'Drug: Pembrolizumab (KEYTRUDA®)', 'Drug: Standard of care (Fruquintinib)']}], 'interventions': [{'name': 'ADG126', 'type': 'DRUG', 'description': 'ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.', 'armGroupLabels': ['ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab', 'ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib', 'ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)']}, {'name': 'Pembrolizumab (KEYTRUDA®)', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®'], 'description': 'Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).', 'armGroupLabels': ['ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab', 'ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib', 'ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)']}, {'name': 'Standard of Care (Trifluridine/Tipiracil-Bevacizumab)', 'type': 'DRUG', 'otherNames': ['Lonsurf and Avastin'], 'description': 'The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.', 'armGroupLabels': ['ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab']}, {'name': 'Standard of care (Fruquintinib)', 'type': 'DRUG', 'otherNames': ['Fruzaqla'], 'description': 'The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.', 'armGroupLabels': ['ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharma Sunil, MD', 'role': 'CONTACT'}], 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daneng Li, MD', 'role': 'CONTACT'}, {'name': 'Marwan Fakih, MD', 'role': 'CONTACT'}], 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patel Manish, MD', 'role': 'CONTACT'}, {'name': 'Rami Guy', 'role': 'CONTACT'}], 'facility': 'Florida cancer specialist/Sarah Cannon Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen, MD', 'role': 'CONTACT'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruihua Xu, MD', 'role': 'CONTACT'}], 'facility': 'SunYat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'George Lau, MD', 'role': 'CONTACT'}], 'facility': 'Hong Kong Humanity & Health Clinical Trial Center', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Brigette B.Y Ma, MD', 'role': 'CONTACT'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '49201', 'city': 'Seogu', 'state': 'Busan Gwangyeogsi', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Yong Oh, MD', 'role': 'CONTACT'}, {'name': 'Grami Dong', 'role': 'CONTACT'}], 'facility': 'Dong -A University Hospital', 'geoPoint': {'lat': 36.74484, 'lon': 127.13739}}, {'zip': '13496', 'city': 'Seongnam', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hing Jae Chon, MD', 'role': 'CONTACT'}, {'name': 'Song I Kang', 'role': 'CONTACT'}], 'facility': 'CHA Bundang Medical Center, CHA university', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yun Gyoo Lee, MD', 'role': 'CONTACT'}], 'facility': 'The Catholic University of Korea Street. Vincent Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '28644', 'city': 'Cheongju-si', 'state': 'North Chungcheong', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki Hyeong Lee, MD', 'role': 'CONTACT'}, {'name': 'Hee Kyung Kim, MD', 'role': 'CONTACT'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byoung Yong Shim, MD', 'role': 'CONTACT'}, {'name': 'Jee Yun Lee, MD', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41931', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Keon Uk Park, MD', 'role': 'CONTACT'}, {'name': 'Ehyun Choi', 'role': 'CONTACT'}], 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seock -Ah Im, MD', 'role': 'CONTACT'}, {'name': 'Sae Won Han, MD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03081', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yun Gyoo Lee, MD', 'role': 'CONTACT'}], 'facility': 'KangBuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sun Young Kim, MD', 'role': 'CONTACT'}, {'name': 'Ko Eun- Young', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Joon Shin, MD', 'role': 'CONTACT'}, {'name': 'Da Seul Lee', 'role': 'CONTACT'}], 'facility': 'Severance Hospital Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Xiaohong She, MS', 'role': 'CONTACT', 'email': 'kristine_she@adagene.com', 'phone': '408-838-9296'}, {'name': 'Jiping Zha, MD, PhD', 'role': 'CONTACT', 'email': 'jiping_zha@adagene.com', 'phone': '650-785-9347'}], 'overallOfficials': [{'name': 'Jiping Zha, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adagene Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adagene Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}