A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
NCT ID: NCT07050459
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
220 participants
INTERVENTIONAL
2025-05-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SIM0686 momo Dose escalation
Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy
SIM0686
Administered intravenously
SIM0686 Corhort expansion
Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications
SIM0686
Administered intravenously
Interventions
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SIM0686
Administered intravenously
SIM0686
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old, male, or female;
* Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
* Participants should have at least one evaluable or measurable tumor lesion (RECIST v1.1);
* Participants have failed the standard of therapy in the locally advanced/metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
* Expected survival ≥12 weeks;
* Adequate organ and bone marrow function;
* 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
Exclusion Criteria
* 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.
* 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.
* 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.
* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
* Has received prior therapies within the following time frames prior to the first dose of study treatment:
1. Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.
2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
3. Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
4. Radiation therapy within 4 weeks.
* Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
* Active or chronic hepatitis B or hepatitis C infection;
18 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SIM0686-101
Identifier Type: -
Identifier Source: org_study_id
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