TST001 for Cancer

Recruiting at 19 trial locations

Overseen By Angela Ireland, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.

Must not be taking: CLDN18.2 agents

Disqualifiers: CNS metastases, Severe cardiovascular disease, Concurrent malignancy, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What safety data exists for TST001 or similar treatments in humans?

The safety of treatments similar to TST001, such as tyrosine kinase inhibitors (TKIs) used for gastrointestinal stromal tumors, has been studied. Common side effects include skin reactions, liver issues, and fever, but no serious safety issues were reported. Some neuropsychiatric side effects have been noted, but overall, these treatments are considered relatively safe. ^{1 2 3 4 5}

Research Team

Charlie Qi, MD

Principal Investigator

Suzhou Transcenta Therapeutics Co.

Eligibility Criteria

Adults with advanced solid tumors, including stomach, gastroesophageal junction, and pancreatic cancers. Participants must have tried standard treatments without success or be unable to tolerate them. They should be in good physical condition (ECOG PS: 0-1) and not have severe heart disease, recent strokes or heart attacks, active infections like hepatitis B/C or HIV/AIDS.

Inclusion Criteria

My cancer is advanced and has been confirmed by lab tests.

I have untreated advanced pancreatic cancer, but may have had prior therapy if my cancer returned 6 months after treatment ended.

I am 18 years old or older.

Exclusion Criteria

I have never been treated with CLDN18.2 targeting drugs.

I haven't had another cancer within the last 5 years, except for certain treated types.

Documented history of multiple other allergies requiring interventions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding (Part A)

Participants receive TST001 in a 3+3 design to determine the dose, dosed every 2 or 3 weeks

Up to 12 weeks

Bi-weekly or tri-weekly visits

Treatment (Part B)

Participants receive TST001 in combination with Nivolumab or standard of care in different cohorts

Up to 24 months

Bi-weekly or tri-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 100 days following last dose

Treatment Details

Interventions

• TST001

Trial Overview TST001 is being tested alone or with other cancer drugs (Nivolumab or standard care chemotherapies) for safety and effectiveness against certain advanced cancers. This trial includes different patient groups based on prior treatment history and specific cancer types.

Participant Groups

Group I: Part B Cohort C Experimental Treatment 3 Interventions

Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.

Group II: Part B Cohort B Experimental Treatment 2 Interventions

Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.

Group III: Part B Cohort A Experimental Treatment 3 Interventions

Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.

Group IV: Part A Q3W Experimental Treatment 1 Intervention

Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.

Group V: Part A Q2W Experimental Treatment 1 Intervention

Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.

Who Is Running the Clinical Trial?

Mabspace Biosciences (Suzhou) Co., Ltd.

Lead Sponsor

Trials

5

Recruited

580+

Suzhou Transcenta Therapeutics Co., Ltd.

Lead Sponsor

Trials

9

Recruited

1,700+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

A review of 81 clinical trials involving over 45,000 patients revealed that the reporting of adverse events (AEs) for targeted therapies and immunotherapies is often inadequate, particularly regarding recurrent/late toxicities and the duration of AEs.

The study highlights that more than 90% of trials failed to adequately report the timing and occurrence of all-grade AEs, indicating a need for improved transparency and detail in AE reporting in future oncology trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. Bossi, P., Botta, L., Bironzo, P., et al.[2020]

A study analyzing 8512 individual case safety reports found that neuropsychiatric adverse drug reactions (ADRs) occurred in 17.8% of cases involving tyrosine kinase inhibitors (TKIs) for gastrointestinal stromal tumors, with avapritinib showing a higher reporting probability for these ADRs.

Notably, avapritinib was associated with rare neuropsychiatric ADRs such as lumbar spinal cord disorders, olfactory nerve disorders, and hallucinations, indicating the need for further research to better understand these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric Adverse Drug Reactions with Tyrosine Kinase Inhibitors in Gastrointestinal Stromal Tumors: An Analysis from the European Spontaneous Adverse Event Reporting System. Barbieri, MA., Sorbara, EE., Russo, G., et al.[2023]

In a study of 470 Japanese patients with imatinib-resistant or intolerant gastrointestinal stromal tumors, sunitinib demonstrated good efficacy with a 20% objective response rate and a median progression-free survival of 22.4 weeks.

The treatment was generally well-tolerated, with 70% of patients experiencing grade ≥ 3 adverse events, but specific early adverse events like hand-foot syndrome and leukopenia were linked to improved progression-free survival, indicating they may serve as positive prognostic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor. Komatsu, Y., Ohki, E., Ueno, N., et al.[2022]

Imatinib mesylate has shown a high clinical response rate of 81.6% in patients with gastrointestinal stromal tumors (GIST), with 53.7% achieving a partial response and 27.9% having stable disease.

While most patients experienced only mild toxicities (grade 1 or 2), 21.1% had more severe side effects (grade 3 or higher), indicating that imatinib is relatively safe but can still cause significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of imatinib for gastrointestinal tumor]. Mizunuma, N.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. [2020]

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

Safety and efficacy of mutant neoantigen-specific T-cell treatment combined anti-PD-1 therapy in stage IV solid tumors. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neuropsychiatric Adverse Drug Reactions with Tyrosine Kinase Inhibitors in Gastrointestinal Stromal Tumors: An Analysis from the European Spontaneous Adverse Event Reporting System. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor. [2022]

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

[The effect of imatinib for gastrointestinal tumor]. [2015]