Recruiting NCT07050459
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SIM0686, SIM0686.
- Who it may be relevant to
- Registry conditions: Locally Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug SIM0686
Administered intravenously - Drug SIM0686
Administered intravenously
Primary outcome measures
- Dose escalation: Dose limited toxicity (DLT) [Time frame: At the end of Cycle 1(each cycle is 21 days)]
- Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: The whole dose escalation phase，an average of 2 years]
- Cohort expansion phase：Overall Response Rate (ORR) [Time frame: The whole Cohort expansion phase，an average of 2 years]
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:
- Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.
- Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
- Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 10 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Harbin Medical University Cancer Hospital — Haerbin
- The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Zhengzhou
- Hunan Cancer Hospital — Changsha
- Nanjing Tianyinshan Hospital — Nanjing
- Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute） — Jinan
- Fudan University Shanghai Cancer Center — Shanghai
- Shanghai Gobroad Cancer Hospital — Shanghai
- … and 2 more centers
Identifiers
NCT: NCT07050459 · SIM0686-101