TerminatedPhase 1

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

Stopped: Corporate Decision

United States19 participantsStarted 2021-06-11

Plain-language summary

This is an open label Phase 1, first-in-human (FIH) study of TST005, a bi-specific antibody consisting of a PD-L1 monoclonal antibody (mAb) and a transforming growth factor beta (TGF-β) trap in subjects with locally advanced or metastatic cancers

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Willing and able to provide signed and dated informed consent
. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, evaluable by RECIST v1.1. (Part B includes metastatic HPV+ malignancies)
. Subject who has tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
. At least one measurable lesion per RECIST 1.1 (Part B only).
. Eastern Cooperative Oncology Group Performance Status (ECOG PS)0\~1.
. Provide archived tumor tissue samples
. Adequate organ function

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing its phases — can you find out why it was stopped, and what that means for the safety or effectiveness of TST005 as a potential treatment option for me?
2Since this was a Phase 1 trial focused on finding a safe dose rather than proving the treatment works, what do we actually know so far about how TST005 performed in patients with locally advanced or metastatic cancers like mine?
3Because the trial is no longer recruiting, are there any other active clinical trials studying TST005 or similar approaches for HPV-related or metastatic solid tumors that might be worth considering?
4Given that this trial targeted a broad group of metastatic solid tumors as well as HPV-related cancers specifically, do you think my cancer type would have even been a good fit, and does that change how we should think about my next steps?
5Are there standard treatments or other ongoing trials that might now be a more reliable path forward, especially since this study was terminated before researchers could establish a recommended Phase 2 dose?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A - Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose(s) (RP2D)

Timeframe: Up to 90 days following last dose

Part B - Patient safety as characterized by frequency and severity of adverse events

Timeframe: Up to 90 days following last dose

Trial details

NCT IDNCT04958434

SponsorSuzhou Transcenta Therapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Locally Advanced or Metastatic Cancers trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Willing and able to provide signed and dated informed consent
. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, evaluable by RECIST v1.1. (Part B includes metastatic HPV+ malignancies)
. Subject who has tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
. At least one measurable lesion per RECIST 1.1 (Part B only).
. Eastern Cooperative Oncology Group Performance Status (ECOG PS)0\~1.
. Provide archived tumor tissue samples
. Adequate organ function

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria