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A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

Status
Active
Cancer Type
Bile Duct Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Stomach/ Gastric Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04396821
Protocol IDs
TST001-1001 (primary)
NCI-2020-05881
Study Sponsor
Mabspace Biosciences (Suzhou) Co., Ltd.

Summary

This is an open label Phase 1, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic, colon and lung cancers.

Objectives

Part A of the trial will consist of two cohorts, one dosed every 2 weeks and one dosed every 3 weeks in a standard 3+3 design. Part A is the dose finding portion of the trial. 27 to 54 participants will be enrolled. Part B consists of 3 cohorts of approximately 20 participants each. For Part B, participants must have CLDN18.2 expressing tumors to qualify for participation. Cohort 1 is for participants with gastric and gastroesophageal junction cancers and dosed every 2 weeks. Cohort 2 is for participants with solid tumors except gastric and gastroesophageal cancers, dosed every 2 weeks. Cohort 3 is for all solid tumors dosed every 3 weeks. Up to 60 participants will be enrolled. The trial will last approximately 2 years, with assessments including safety labs, ECGs, MUGA scans, PKs and PDs and CT/MRI tumor assessments, based on the Q2W and Q3W dosing schedules.

Eligibility

  1. Willing and able to provide signed and dated informed consent
  2. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.
  3. Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy. d) Patients with HER2+ GC/GEJ cancer must have progressed after HER2-targeted therapy.
  4. CLDN18.2 expression in tumor (Part B only): patients with locally advanced or metastatic unresectable GC, GEJ cancer, or other solid tumor including but not limited to pancreatic cancer, cholangiocarcinoma, ovarian cancer, and lung cancer.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS): Part A 0~1, Part B 0~2.
  6. Life expectancy = 3 months.
  7. At least one measurable lesion per RECIST 1.1 (Part B only).
  8. Provide archived tumor tissue samples
  9. Adequate organ function
  10. Recover to Grade 0-1 from adverse events related to prior anti-cancer therapy except alopecia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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