47 Participants Needed

hSTC810 for Solid Tumors

Recruiting at 4 trial locations
YJ
Overseen ByYujin Jung
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment hSTC810 for solid tumors?

Research suggests that targeting butyrophilin proteins, like those in hSTC810, can help the immune system attack cancer cells more effectively by enhancing the activity of certain immune cells (T cells) against tumors. This approach has shown promise in improving survival in various cancer models.12345

What safety data exists for bispecific antibodies like hSTC810 in humans?

Bispecific antibodies, like hSTC810, have been associated with side effects such as cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly) and infections, which are common during treatment. Early intervention with medications like tocilizumab can prevent severe symptoms, and monitoring for infections is important. Other side effects may include skin and nail disorders and loss of taste, depending on the specific target of the antibody.678910

What makes the drug hSTC810 unique for treating solid tumors?

hSTC810 is a bispecific antibody, which means it can bind to two different targets at once, potentially enhancing its ability to direct the immune system to attack cancer cells. This approach is similar to other bispecific antibodies used in blood cancers, but its application in solid tumors is novel, offering a new strategy for targeting these types of cancers.910111213

Research Team

Md

Medical director

Principal Investigator

STCube, Inc.

Eligibility Criteria

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.
I am 18 years old or older.
See 3 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.
I haven't had any cancer treatment in the last 4 weeks.
See 16 more

Timeline

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

Treatment Details

Interventions

  • hSTC810
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: hSTC810Experimental Treatment1 Intervention
6 escalating doses of hSTC810 will be administered to participants

Find a Clinic Near You

Who Is Running the Clinical Trial?

STCube, Inc.

Lead Sponsor

Trials
3
Recruited
250+

References

Cancer cell-expressed BTNL2 facilitates tumour immune escape via engagement with IL-17A-producing γδ T cells. [2022]
Butyrophilin-like 9 expression is associated with outcome in lung adenocarcinoma. [2023]
BTN3A1 governs antitumor responses by coordinating αβ and γδ T cells. [2021]
Frontline: Characterization of BT3 molecules belonging to the B7 family expressed on immune cells. [2021]
Multi-omics analysis of the expression and prognostic value of the butyrophilins in breast cancer. [2021]
Platelets subvert antitumor efficacy of T cell-recruiting bispecific antibodies. [2022]
A novel bispecific c-MET/CTLA-4 antibody targetting lung cancer stem cell-like cells with therapeutic potential in human non-small-cell lung cancer. [2020]
Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies. [2023]
T-cell redirecting bispecific antibodies in multiple myeloma: Current landscape and future directions. [2023]
Bispecific antibodies in haematological malignancies. [2018]
Bispecific antibody-mediated cytotoxicity by CD4+ and CD8(+)-activated T cells generated from leukemia patients after allogeneic bone marrow transplantation. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Redirecting T cells to hematological malignancies with bispecific antibodies. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
ABBV-184: A Novel Survivin-specific TCR/CD3 Bispecific T-cell Engager is Active against Both Solid Tumor and Hematologic Malignancies. [2023]