hSTC810 for Solid Tumors

No longer recruiting at 6 trial locations
YJ
Overseen ByYujin Jung
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called hSTC810, an experimental antibody therapy, to determine its safety and tolerability for people with advanced solid tumors, such as those in the liver or lungs. Researchers examine how the body processes the drug and whether it shows any signs of effectiveness against cancer. Participants receive varying doses to identify the optimal and safest amount. This trial may suit individuals with advanced cancer who have not recently undergone other treatments and do not have active infections or major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have received anti-cancer treatment, radiotherapy, or major surgery within 4 weeks before starting the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that hSTC810 is likely to be safe for humans?

Research has shown that hSTC810, also known as Nelmastobart, was tested for safety in earlier studies. These studies involved patients with advanced solid tumors and found that hSTC810 was generally safe. Participants handled the treatment well, and no major safety issues were reported. Early results also suggested that the treatment might be effective. For those considering joining this trial, this early research offers a reassuring view of the treatment's safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, which often include chemotherapy, radiation, or surgery, hSTC810 is unique because it introduces a novel mechanism of action. Researchers are excited about hSTC810 because it targets specific pathways within cancer cells, potentially leading to more precise and effective results with fewer side effects. This targeted approach could offer new hope for patients whose tumors don't respond well to existing therapies, providing a more tailored and potentially more successful treatment option.

What evidence suggests that hSTC810 might be an effective treatment for solid tumors?

Research shows that hSTC810, also known as Nelmastobart, is a specially designed antibody targeting a protein found in many solid tumors. Studies have found that this treatment can help patients with advanced solid tumors by slowing tumor growth. It blocks a protein that aids cancer cell survival. Some patients have responded well, with their cancer not worsening. While early results are promising, further research is needed to confirm its effectiveness.12567

Who Is on the Research Team?

Md

Medical director

Principal Investigator

STCube, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

At least one measurable lesion as determined by RECIST Ver.1.1
Your doctor believes that you will likely live for at least 12 more weeks.
For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose.
See 2 more

Exclusion Criteria

I need high doses of steroids or other drugs that weaken my immune system.
You have had a transplant using someone else's stem cells or organs in the past.
Subject with active HBV or HCV infection
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of hSTC810 to evaluate safety, tolerability, and pharmacokinetics

4 weeks
Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Long-term follow-up

Participants are monitored for overall survival and other long-term outcomes

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • hSTC810
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: hSTC810Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

STCube, Inc.

Lead Sponsor

Trials
3
Recruited
250+

Citations

A phase I study of nelmastobart (hSTC810), an anti- ...This phase I study describes the safety and clinical activity of Nelmastobart (hSTC810), a humanized monoclonal antibody targeting BTN1A1, in pts with advanced ...
Nelmastobart - Drug Targets, Indications, PatentsAnti STT-003 Ab, Anti-butyrophilin 1A1 mAb(STCube/MD Anderson Cancer Center) ... Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors.
1456 A phase I study of hSTC810 (Nelmastobart), an anti- ...This Phase I study evaluates the safety and clinical activity of hSTC810 (Nelmastobart), a humanized monoclonal antibody targeting BTN1A1, in ...
A Study of hSTC810 With Advanced/Metastatic Solid ...Publications (6) · Outcome · Baseline Char. (24) · Response Rates (7) · Adverse Events (11) · Timelines (2) ...
Abstract C066: Update on the phase 1 trial of Nelmastobart ...In this phase, 1 clinical trial, the safety and preliminary efficacy of Nelmastobart (hSTC81), a humanized monoclonal antibody targeting BTN1A1, was evaluated ...
High dose acetaminophen inhibits STAT3 and has free ...There are no agents with known anti-CSC effects approved by FDA for solid tumors, including nonsmall cell lung cancer. As AAP (with NAC ...
nelmastobart (STT-003) NewsConclusions : Preliminary results from the TMA analysis and Phase 1 trial suggest that targeting BTN1A1 with Nelmastobart is safe and shows early signs of ...
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