RecruitingPhase 1NCT07348211

First in Human Study of SIM0610 in Solid Tumors

An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors


Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

260 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new cancer drug called SIM0610 for people with advanced solid tumors (cancer that has spread and cannot be cured with standard treatments). The study starts with finding a safe dose, then expands to specific cancer types including lung cancer, liver cancer, head and neck cancer, and colorectal cancer. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic solid tumor cancer - Your cancer has progressed despite at least one prior standard treatment - You are in good physical condition (ECOG 0 or 1) - Your expected survival is at least 12 weeks - You can swallow tablets and have good organ function **You may NOT be eligible if...** - You have had another active cancer in the past 2 years - You have cancer in the brain causing symptoms or requiring treatment - You have had lung inflammation (ILD) requiring steroids - You have uncontrolled fluid buildup around the heart, lungs, or abdomen - You have had a recent heart attack, stroke, or severe heart failure - You have HIV, active infections requiring treatment, or had an organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSIM0610 for Injection

intravenous infusion

DRUGSIM0610 for Injection

intravenous infusion


Locations(7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

the First Hospital of China Medical University

Shenyang, Liaoning, China

The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07348211


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