Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-01 @ 7:34 PM
Study NCT ID:
NCT06399757
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D002288', 'term': 'Adenocarcinoma, Mucinous'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events [Safety]', 'timeFrame': 'Through study completion, approximately one year', 'description': 'Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.'}, {'measure': 'Incidence of dose limiting toxicities [Tolerability] (Phase 1)', 'timeFrame': 'Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)', 'description': 'Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results'}, {'measure': 'Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)', 'timeFrame': 'Approximately one year'}, {'measure': 'Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)', 'timeFrame': 'Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)', 'description': 'Response is assessed per RECIST version 1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)', 'timeFrame': 'Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)', 'description': 'Response is assessed per RECIST version 1.1 criteria'}, {'measure': 'Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)', 'timeFrame': 'On days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).', 'description': 'Evaluate PK parameters: oral clearance'}, {'measure': 'Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)', 'timeFrame': 'On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).', 'description': 'Evaluate PK parameters: volume of distribution'}, {'measure': 'Further assess the anti-tumor activity of APL-5125 (Phase 2)', 'timeFrame': 'Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)', 'description': 'Response is assessed per RECIST version 1.1 criteria'}, {'measure': 'Incidence of treatment emergent adverse events [Further Safety] (Phase 2)', 'timeFrame': 'Through study completion (approximately 2 years)', 'description': 'Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results'}, {'measure': 'Further assess the PK of APL-5125 (Phase 2)', 'timeFrame': 'On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).', 'description': 'Evaluate PK parameters: oral clearance'}, {'measure': 'Further assess the PK of APL-5125 (Phase 2)', 'timeFrame': 'On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).', 'description': 'Evaluate PK parameters: volume of distribution'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Cholangiocarcinoma', 'Appendiceal Adenocarcinoma', 'Pancreatic Adenocarcinoma', 'Gastric Adenocarcinoma', 'Endometrial Adenocarcinoma', 'Triple Negative Breast Cancer', 'Ovarian Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.\n* For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer\n* Phase 2: Colorectal carcinoma\n* No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents:\n\n * fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy\n * an anti-VEGF therapy\n * if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy\n* Eastern Cooperative Oncology Group (ECOG) ≤1\n* Body Weight ≥40 kg.\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening\n* Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days\n* Major surgery within 1 month of screening\n* Hemoglobin \\< 9.0 g/dL\n* Absolute neutrophil count \\< 1.5 x 10\\^9/L\n* Platelet count \\< 100 x 10\\^9/L\n* Hepatic function:\n\n 1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN) (\\>5 x ULN for subjects with liver metastases)\n 2. Total bilirubin \\>1.5 × ULN (except participants with Gilbert's syndrome).\n 3. Albumin \\< 3 g/dL\n* Calculated or measured creatinine clearance of \\<60 mL/minute calculated using the formula of Cockcroft and Gault (\\[140 - Age\\] × Mass \\[kg\\] / \\[72 × serum creatinine mg/dL\\]). Multiply result by 0.85 if female.\n* Fridericia's corrected QT interval (QTcF) \\>470 msec or a family history of Long QT Syndrome.\n* Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) \\<45% at rest\n* Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C"}, 'identificationModule': {'nctId': 'NCT06399757', 'briefTitle': 'A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apollo Therapeutics Ltd'}, 'officialTitle': 'A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'AP10CP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose Escalation', 'description': 'Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose.\n\nPossibility to expand into select populations', 'interventionNames': ['Drug: APL-5125']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Dose Expansion/Optimization', 'description': 'At least 2 dose levels of APL-5125 in a selected population', 'interventionNames': ['Drug: APL-5125']}], 'interventions': [{'name': 'APL-5125', 'type': 'DRUG', 'description': 'APL-5125 is an oral drug (capsule) taken daily in 28-day cycles', 'armGroupLabels': ['Phase 1: Dose Escalation', 'Phase 2: Dose Expansion/Optimization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope Orange County Lennar Foundation Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carly Taylor', 'role': 'CONTACT', 'email': 'ctaylor@flcancer.com'}], 'facility': 'Florida Cancer Specialists & Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'University of Michigan Cancer AnswerLine', 'role': 'CONTACT', 'email': 'CancerAnswerLine@med.umich.edu', 'phone': '800-865-1125'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sabina Wlazlo Cascalheiro', 'role': 'CONTACT', 'email': 'sabina.wlazlo@duke.edu', 'phone': '919-613-4812'}], 'facility': 'Duke Cancer Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Wall', 'role': 'CONTACT', 'email': 'hwall@carolinabiooncology.org', 'phone': '980-441-1148'}, {'role': 'CONTACT', 'phone': '704-947-6599'}], 'facility': 'Carolina BioOncology Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Department Contact', 'role': 'CONTACT', 'email': 'referral@marycrowley.org'}], 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Georg', 'role': 'CONTACT', 'email': 'jgeorg@nextoncology.com', 'phone': '210-580-9521'}], 'facility': 'NEXT Oncology- San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Apollo Therapeutics', 'role': 'CONTACT', 'email': 'AP10@apollotx.com', 'phone': '781-479-2267'}], 'overallOfficials': [{'name': 'Sanjay Aggarwal, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Apollo Therapeutics Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apollo Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}