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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Suzhou Transcenta Therapeutics Co., Ltd.
Study ID
NCT04396821
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TST001 — DRUG
    TST001 is a humanized IgG1 monoclonal antibody.
  • Nivolumab Injection [Opdivo] — DRUG
    Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies
  • mFOLFOX6 — DRUG
    mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
  • Gemcitabine — DRUG
    Chemotherapy medication
  • Albumin-Bound Paclitaxel — DRUG
    Chemotherapy medication

Study Details

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.

Key Dates

Start date
May 28, 2020
Status verified
Nov 2025
Primary completion
May 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Q2W
    Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.
  • Experimental: Part A Q3W
    Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.
  • Experimental: Part B Cohort A
    Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.
  • Experimental: Part B Cohort B
    Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.
  • Experimental: Part B Cohort C
    Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.

Primary Outcome Measure

Participant Safety as characterized by frequency and severity of adverse events [ Time Frame: up to 100 days following last dose ]

Locations (18)

FacilityCityStateZIPSite coordinators
Banner MD AndersonGilbertArizona85234-
University of ArizonaTucsonArizona85724-
Yale UniversityNew HavenConnecticut06519-
Florida Cancer SpecialistsSarasotaFlorida34232-
Emory UniversityAtlantaGeorgia30033-
University of Kansas, School of MedicineKansas CityKansas66160-
Washington UniversitySt LouisMissouri63110-
Memorial Sloan KetteringNew YorkNew York10065-
Stony Brook Cancer CenterStony BrookNew York11794-
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Gabrail Cancer ResearchCantonOhio44718-
Pennsylvania Cancer Specialist Research InstituteGettysburgPennsylvania17325-
Allegheny HospitalPittsburghPennsylvania15212-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt UniversityNashvilleTennessee37232-
NEXT OncologyAustinTexas78704-
Swedish Cancer InstituteSeattleWashington98104-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Gilbert, AZ

By condition
Gastric cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Banner MD Anderson· Gilbert, AZUniversity of Arizona· Tucson, AZYale University· New Haven, CTFlorida Cancer Specialists· Sarasota, FLEmory University· Atlanta, GAUniversity of Kansas, School of Medicine· Kansas City, KS

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