NCT07050459 A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
| NCT ID | NCT07050459 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
| Condition | Locally Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2025-05-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Voluntary participation and signature of informed consent form; * 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: * 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. * 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07050459 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07050459 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07050459 currently recruiting?
Yes, NCT07050459 is actively recruiting participants. Contact the research team at zhangzhi4@zaiming.com for enrollment information.
Where is the NCT07050459 trial being conducted?
This trial is being conducted at Beijing, China, Haerbin, China, Zhengzhou, China, Changsha, China and 6 additional locations.
Who is sponsoring the NCT07050459 clinical trial?
NCT07050459 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. The trial plans to enroll 220 participants.