RecruitingPhase 1NCT07390838

A Study of SH009 Injection in Patients With Advanced Solid Tumors.

An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.


Sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Enrollment

150 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new experimental drug called SH009 in people with advanced solid tumors (cancer that has spread or cannot be removed surgically) who have already tried at least one standard treatment. This is an early-phase study primarily focused on safety and determining the right dose, but also looking at whether the drug has anti-cancer effects. **You may be eligible if...** - You are 18 or older - You have advanced, recurrent, or metastatic solid tumor cancer (such as colorectal, stomach, liver, head and neck, breast, lung, or esophageal cancer) confirmed by biopsy - You have already tried at least one standard treatment and it stopped working or caused intolerable side effects - You have no other acceptable treatment options - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have not tried any prior treatment - You have serious uncontrolled organ problems (heart, liver, kidneys) - You have certain active infections or serious autoimmune conditions - 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

DRUGSH009

The dosage of SH009 is 40 mg/kg QW with a treatment cycle of 28 days


Locations(1)

Shanghai Gaobo Cancer Hospital

Shanghai, China

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NCT07390838


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