TSN084 for Cancer

Overseen By Cindy Li

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tyligand Bioscience (Shanghai) Limited

Must not be taking: QT prolonging drugs, CYP3A drugs

Disqualifiers: Hepatitis, HIV, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TSN084, which aims to stop cancer growth by blocking certain proteins. It is for patients with advanced or spreading cancers who may not respond to other treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any investigational drugs or other anti-tumor drugs within 21 days before starting the trial, and you should not use strong inducers or inhibitors of CYP3A drugs.

What safety data exists for TSN084 or similar treatments?

The study on a lipid-conjugated estrogenic derivative (ESC8), which may be related to TSN084, showed it was nontoxic and effective in inhibiting tumor growth in mice with breast cancer. It was tested for safety in rats and mice, showing it was well-tolerated and had a good safety profile. ^{1 2 3 4 5}

How does the drug TSN084 differ from other cancer treatments?

TSN084 may target the transmembrane protein 88 (TMEM88), which is involved in regulating cell growth and tumor progression by affecting signaling pathways like Wnt/β-catenin. This approach is different from traditional cancer treatments like surgery and chemotherapy, as it focuses on specific molecular targets within cancer cells. ^{6 7 8 9 10}

Research Team

Siqing FU, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults (18+) with advanced or metastatic malignancies, who have an expected survival of at least 12 weeks and are not suitable for standard therapy. They must understand the study, consent to participate, and be able to follow procedures. Their organ functions should meet specific criteria, they cannot be pregnant or breastfeeding, and must agree to use contraception.

Inclusion Criteria

Not deemed as potentially unreliable and/or uncooperative

I am 18 years old or older.

Survival expectations are ≥ 12 weeks

Exclusion Criteria

I am currently being treated for a mental health disorder.

Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation

I do not have an active syphilis or tuberculosis infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TSN084 to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy

8 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TSN084

Trial Overview TSN084 is being tested in this first-in-human trial to find the highest dose patients can take without serious side effects (MTD), identify any dose-limiting toxicities (DLT), explore how the body processes it (pharmacokinetics), check its safety profile, and see if it shrinks tumors.

Participant Groups

Group I: TSN084 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Tyligand Bioscience (Shanghai) Limited

Lead Sponsor

Trials

4

Recruited

500+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Erlotinib augmentation with dapsone for rash mitigation and increased anti-cancer effectiveness. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Significance of the IL-8 pathway for immunotherapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Crosstalk between stromal components and tumor cells of TNBC via secreted factors enhances tumor growth and metastasis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Lipid nanocarriers of a lipid-conjugated estrogenic derivative inhibit tumor growth and enhance cisplatin activity against triple-negative breast cancer: pharmacokinetic and efficacy evaluation. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Interleukin-8 increases vascular endothelial growth factor and neuropilin expression and stimulates ERK activation in human pancreatic cancer. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

FAM84B promotes breast cancer tumorigenesis through activation of the NF-κB and death receptor signaling pathways. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Tspan8 is expressed in breast cancer and regulates E-cadherin/catenin signalling and metastasis accompanied by increased circulating extracellular vesicles. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting TMEM88 as an Attractive Therapeutic Strategy in Malignant Tumors. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

TMEM88 exhibits an antiproliferative and anti-invasive effect in bladder cancer by downregulating Wnt/β-catenin signaling. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

KRT81 Knockdown Inhibits Malignant Progression of Melanoma Through Regulating Interleukin-8. [2021]