TST003 for Cancer

Recruiting at 2 trial locations

Overseen By Lei Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

Must not be taking: Steroids, Chemotherapy, Immunotherapy, others

Disqualifiers: CNS metastases, Cardiovascular disease, Infections, others

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

Compensation: Varies

Number of Visits: 2

111 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests TST003, a new drug for treating advanced cancers. It focuses on patients with advanced or metastatic solid tumors and later specifically on colorectal cancer. The drug is given through a vein, and doctors will monitor its safety, side effects, and effectiveness.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had any systemic anti-cancer treatment within 4 weeks before starting the trial drug.

What data supports the effectiveness of the drug TST003 for cancer?

The drug TS-1, which is part of the TST003 treatment, has shown effectiveness in treating various cancers, including gastric and head and neck cancers, by shrinking tumors and improving survival rates. In studies, TS-1 has been effective in both inoperable and recurrent gastric cancer, with a notable response rate and some patients achieving long-term survival. ^{1 2 3 4 5}

What safety data exists for TST003 (also known as TS-1) in humans?

TS-1 has been studied for safety in various cancers, showing a high incidence of adverse reactions like myelosuppression (reduced bone marrow activity) and gastrointestinal issues, with severe reactions such as leukopenia (low white blood cell count), thrombocytopenia (low platelet count), and Stevens-Johnson syndrome (a serious skin condition) occurring in some cases. Careful monitoring is essential to manage these risks. ^{3 6 7 8 9}

Eligibility Criteria

Adults with certain advanced solid tumors, measurable lesions (for Phase Ib), and no standard treatment options left. They must be in good general health with proper organ function, not pregnant or nursing, and willing to use contraception. People who've had recent cancer treatments or severe illnesses are excluded.

Inclusion Criteria

I am 18 years old or older.

My cancer has worsened despite treatment and there are no standard treatments left.

My liver tests for bilirubin, ALT, and AST are within normal limits.

Exclusion Criteria

I have brain metastases but haven't needed steroids for them in the last 4 weeks.

My heart's electrical activity (QT interval) is longer than normal or I have risk factors for irregular heartbeat.

I have had serious bleeding in my stomach or intestines in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2-4 visits (in-person)

Dose Escalation

Participants receive TST003 intravenously at increasing doses every 3 weeks to determine the recommended Phase 2 dose

Varies based on dose escalation schedule

Several visits after each dose for safety evaluations

Dose Expansion

Participants receive TST003 at the recommended Phase 2 dose every 3 weeks to assess efficacy and safety

Up to 1 year

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TST003

Trial Overview TST003 is being tested for safety in cancer patients. The study will determine the safe dosage level, how long it stays in the body, side effects experienced by participants, and if it helps shrink their tumors. It's given intravenously every three weeks as long as benefits continue.

Participant Groups

Group I: Phase 1b Part - Dose Expansion at Recommended Phase 2 dose Experimental Treatment 1 Intervention

Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose,

Group II: Phase 1a Part - TST003 Dose Escalation Experimental Treatment 1 Intervention

TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg

Who Is Running the Clinical Trial?

Suzhou Transcenta Therapeutics Co., Ltd.

Lead Sponsor

Trials

9

Recruited

1,700+

Findings from Research

In a study of 67 patients with inoperable and recurrent gastric cancer, TS-1 therapy demonstrated a clinical efficacy with an overall response rate of 41%, particularly effective for peritoneal dissemination (57.1% response rate).

The treatment was found to be safe, with only 12.8% of patients experiencing severe adverse reactions (grade 3 or 4), and it resulted in a median survival time of 276 days, with notable long-term survival cases exceeding 2.5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of TS-1 for inoperative and recurrent gastric cancer and evaluation of long survival cases]. Tanabe, K., Yoshida, K., Hamai, Y., et al.[2013]

In a safety investigation involving 3,882 patients starting TS-1 therapy, the overall incidence of adverse reactions was 74.3%, with high rates of myelosuppression and gastrointestinal disorders, indicating significant side effects associated with this treatment.

The study highlighted the importance of safety monitoring and collaboration between healthcare providers to ensure proper patient eligibility and regular laboratory testing, which proved effective in managing the risks of serious adverse reactions during the early marketing period of TS-1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Example of safety measures for antineoplastic agents immediately after market launch--a case of TS-1 capsule all example use result investigation that executes safety monitoring--]. Ito, K.[2019]

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.

The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. Rong, L., Xie, M., Jiang, M., et al.[2023]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Doxifluridine combined with weekly paclitaxel for second-line treatment in patients with gastric cancer resistant to TS-1. [2018]

2. England pubmed.ncbi.nlm.nih.gov

A Phase I/II trial of radiotherapy concurrent with TS-1 plus cisplatin in patients with clinically resectable type 4 or large type 3 gastric cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1205. [2013]

3. Japan pubmed.ncbi.nlm.nih.gov

[A Resectable Case of TS-1 Therapy Useful in Distinguishing Primary Lung Cancer from Lung Metastases of Pancreatic Cancer]. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

[Two head and neck cancer patients who responded to chemotherapy consisting of only TS-1]. [2013]

5. Japan pubmed.ncbi.nlm.nih.gov

[Clinical study of TS-1 for inoperative and recurrent gastric cancer and evaluation of long survival cases]. [2013]

6. Japan pubmed.ncbi.nlm.nih.gov

[Example of safety measures for antineoplastic agents immediately after market launch--a case of TS-1 capsule all example use result investigation that executes safety monitoring--]. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[The usefulness of TS-1 for the treatment of head and neck cancer]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. [2023]

9. Japan pubmed.ncbi.nlm.nih.gov

[Examination of the feasibility of TS-1 for postoperative advance stomach cancer patients]. [2013]