Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-20 @ 10:48 AM
Study NCT ID:
NCT07050459
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose escalation: Dose limited toxicity (DLT)', 'timeFrame': 'At the end of Cycle 1(each cycle is 21 days)', 'description': 'DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).'}, {'measure': 'Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'The whole dose escalation phase，an average of 2 years', 'description': 'Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.'}, {'measure': 'Cohort expansion phase：Overall Response Rate (ORR)', 'timeFrame': 'The whole Cohort expansion phase，an average of 2 years', 'description': 'ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary participation and signature of informed consent form;\n* At least 18 years old, male, or female;\n* Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;\n* Participants should have at least one evaluable or measurable tumor lesion (RECIST v1.1);\n* Participants have failed the standard of therapy in the locally advanced/metastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n* Expected survival ≥12 weeks;\n* Adequate organ and bone marrow function;\n* Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 6 months before first administration for evaluation of FGFR2b expression levels\n\nExclusion Criteria:\n\n* Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.\n* Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.\n* Has received prior therapies within the following time frames prior to the first dose of study treatment:\n\n 1. Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.\n 2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).\n 3. Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.\n 4. Radiation therapy within 4 weeks.\n* Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* Active or chronic hepatitis B or hepatitis C infection;'}, 'identificationModule': {'nctId': 'NCT07050459', 'briefTitle': 'A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'SIM0686-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIM0686 momo Dose escalation', 'description': 'Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy', 'interventionNames': ['Drug: SIM0686']}, {'type': 'EXPERIMENTAL', 'label': 'SIM0686 Corhort expansion', 'description': 'Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications', 'interventionNames': ['Drug: SIM0686']}], 'interventions': [{'name': 'SIM0686', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['SIM0686 Corhort expansion']}, {'name': 'SIM0686', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['SIM0686 momo Dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Wang, PHD', 'role': 'CONTACT', 'email': 'zlhuxi@163.com', 'phone': '+8613910704669'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '150081', 'city': 'Haerbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tongsen Zheng, PHD', 'role': 'CONTACT', 'email': 'yqbfzhengtongsen@163.com', 'phone': '+8615134569619'}, {'name': 'Yan Yu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harbin Medical University Cancer Hospital'}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiming Wang, PHD', 'role': 'CONTACT', 'email': 'qimingwang1006@126.com', 'phone': '+8613783590691'}], 'facility': 'The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410017', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyang Liu, PHD', 'role': 'CONTACT', 'email': 'liuzhenyang@hnca.org.cn', 'phone': '+8618673181133'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shukui Qin, PHD', 'role': 'CONTACT', 'email': 'qinsk81@163.com', 'phone': '+8613905158713'}], 'facility': 'Nanjing Tianyinshan Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqin Ni, PHD', 'role': 'CONTACT', 'email': 'nsq163@163.com', 'phone': '+8615553115936'}], 'facility': 'Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhang, PHD', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '+8618017312991'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200131', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Lin, PHD', 'role': 'CONTACT', 'email': 'jin.li@gobroadhealthcare.com', 'phone': '+8613761222111'}], 'facility': 'Shanghai Gobroad Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610040', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tongyu Lin, PHD', 'role': 'CONTACT', 'email': 'lintongyu@scszlyy.org.cn', 'phone': '+8613926400320'}], 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Deng, PHD', 'role': 'CONTACT', 'email': 'xymcdengting@126.com', 'phone': '+8615802243063'}], 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zhi Zhang', 'role': 'CONTACT', 'email': 'zhangzhi4@zaiming.com', 'phone': '+8618670738874'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}