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hSTC810 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by STCube, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS score ≤ 1
Be older than 18 years old
Must not have
Subject who requires high dose of steroids or other immunosuppressive medications
Any toxicity due to prior therapy that has not resolved to ≤ Grade 1 or returned to baseline by the time of starting study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called hSTC810 in patients with advanced solid tumors. The study will check if the drug is safe, how well patients can tolerate it, and how it behaves in the body. Researchers will also look at early signs of how effective the drug might be.

Who is the study for?
This trial is for adults with advanced solid tumors who have a life expectancy of at least 12 weeks, can consent to the study, and agree to use contraception. They must have at least one measurable tumor and be in good physical condition (ECOG PS ≤1). People with active brain metastases, recent cancer treatments or major surgeries, certain infections like hepatitis or COVID-19, autoimmune diseases needing treatment within 2 years, severe allergies to checkpoint inhibitors, or serious heart conditions cannot join.
What is being tested?
The trial is testing hSTC810 as a solo therapy for people with advanced solid tumors. It aims to evaluate how safe it is and how the body processes it (pharmacokinetics), along with an initial look at its effectiveness against the tumors.
What are the potential side effects?
While specific side effects of hSTC810 are not listed here, common side effects from similar therapies may include fatigue, nausea, skin reactions at injection sites, immune-related issues such as inflammation in organs like lungs or intestines; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need high doses of steroids or other drugs that weaken my immune system.
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Any side effects from my previous treatments have mostly gone away.
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I am currently being treated for an infection with medication.
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I have active tuberculosis.
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My cancer has spread to my brain.
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I have not received a live vaccine in the last 30 days.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have a known history of HIV.
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I have a history of lung scarring or inflammation not caused by infections.
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I have not had radiotherapy or major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of AEs, SAEs, and abnormalities in Lab
Incidence of DLTs
Secondary study objectives
Area under the plasma concentration - time curve (AUC0-t)
Best overall response (BOR)
Clinical Benefit rate (CBR)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: hSTC810Experimental Treatment1 Intervention
6 escalating doses of hSTC810 will be administered to participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hSTC810
2022
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

STCube, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Medical directorStudy DirectorSTCube, Inc.
1 Previous Clinical Trials
3,032 Total Patients Enrolled

Media Library

hSTC810 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05231746 — Phase 1
Solid Tumors Research Study Groups: hSTC810
Solid Tumors Clinical Trial 2023: hSTC810 Highlights & Side Effects. Trial Name: NCT05231746 — Phase 1
hSTC810 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231746 — Phase 1
~13 spots leftby Dec 2025
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