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

NCT04396821 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TST001-1001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Advanced Cancer; Gastric Cancer; Gastroesophageal-junction Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (5)

• Participant Safety as characterized by frequency and severity of adverse events

  Characterization of TST001 safety profile including frequency and severity of adverse events that are related to treatment.

  up to 100 days following last dose

• Maximum Tolerated Dose (MTD or Recommended Phase 2 Dose (RP2D)

  As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort

  up to 100 days following last dose

• Participant Safety and Tolerability of TST001 in combination with Nivolumab as characterized by frequency and severity of adverse events

  Characterization of TST001 + Nivolumab safety profile including frequency and severity of adverse events that are related to treatment.

  Up to 100 days following last dose

• Participant Safety and Tolerability of TST001 in combination with Nivolumab and mFOLFOX6 as characterized by frequency and severity of adverse events

  Characterization of TST001 + Nivolumab + mFOLFOX6 safety profile including frequency and severity of adverse events that are related to treatment.

  Up to 100 days following last dose

• Participant Safety and Tolerability of TST001 in combination with gemcitabine and albumin-bound paclitaxel as characterized by frequency and severity of adverse events

  Characterization of TST001 + Gemcitabine + albumin-bound paclitaxel safety profile including frequency and severity of adverse events that are related to treatment.

  Up to 100 days following last dose

Secondary Outcomes (7)

• Immunogenicity

  up to 30 days following last dose

• Objective response rate (ORR)

  up to 24 months, until disease progression or start of another anti-cancer therapy

• Duration of Response (DOR)

  up to 24 months, until disease progression or start of another anti-cancer therapy

• Progression free survival (PFS)

  up to 24 months, until disease progression or start of another anti-cancer therapy

• PK parameters

  Up to 30 days following last dose

Study Arms (5)

Part A Q2W

EXPERIMENTAL

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

Drug: TST001

Part A Q3W

EXPERIMENTAL

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

Drug: TST001

Part B Cohort A

EXPERIMENTAL

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

Drug: TST001; Drug: Nivolumab Injection [Opdivo]; Drug: mFOLFOX6

Part B Cohort B

EXPERIMENTAL

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

Drug: TST001; Drug: Nivolumab Injection [Opdivo]

Part B Cohort C

EXPERIMENTAL

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

Drug: TST001; Drug: Gemcitabine; Drug: Albumin-Bound Paclitaxel

Interventions

Nivolumab Injection [Opdivo] DRUG

Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies

Part B Cohort A; Part B Cohort B

mFOLFOX6 DRUG

mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.

Part B Cohort A

Gemcitabine DRUG

Chemotherapy medication

Also known as: Gemzar

Part B Cohort C

TST001 DRUG

TST001 is a humanized IgG1 monoclonal antibody.

Part A Q2W; Part A Q3W; Part B Cohort A; Part B Cohort B; Part B Cohort C

Albumin-Bound Paclitaxel DRUG

Chemotherapy medication

Part B Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years.
• Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.
• Part A only:
• \* Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy.
• Part B only:
• Cohort A: Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received one infusion of mFOLFOX6 plus nivolumab during the screening period.
• Cohort B: Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies; adjuvant or neoadjuvant therapy could be regarded as one line of therapy only if disease progressed or recurred during these treatments or within 6 months or less after completion of these treatments.
• Cohort C: Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received up to 2 infusions of Gemcitabine + albumin-bound paclitaxel (with one week between each infusion) during the screening period.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 .
• Patients with adequate cardiac, liver, renal function, etc.

You may not qualify if:

• Symptomatic central nervous system metastases.
• Prior treatment with any CLDN18.2 target agents
• Allergy or sensitivity to TST001 or known allergies to comparable drugs
• Documented history of multiple other allergies requiring interventions
• Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina, NYHA class III or IV heart failure or uncontrolled arrhythmia within 6 months of study entry, severe QTc prolongation, concomitant risks for QTc prolongation.
• Concurrent malignancy within 5 years prior to entry except adequately treated certain types of cancer
• Active and clinically significant infections, known uncontrolled infections with hepatitis B, hepatitis C, known human immunodeficiency virus with acquired immunodeficiency syndrome related illness
• Any condition that the investigator or primary physician believes may not be appropriate for participating in the study.

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• Suzhou Transcenta Therapeutics Co., Ltd.: lead

Study Sites (18)

Banner MD Anderson

Gilbert, Arizona, 85234, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Emory University

Atlanta, Georgia, 30033, United States

Location

University of Kansas, School of Medicine

Kansas City, Kansas, 66160, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Gabrail Cancer Research

Canton, Ohio, 44718, United States

Location

Pennsylvania Cancer Specialist Research Institute

Gettysburg, Pennsylvania, 17325, United States

Location

Allegheny Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

NEXT Oncology

Austin, Texas, 78704, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Nivolumab; Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Study Officials

• Charlie Qi, MD

  Suzhou Transcenta Therapeutics Co.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A - 2 arms, Q2w and Q3w, 3+3 design dose escalation; Part B - dose expansion, 3 Cohorts

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 21, 2020
• Study Start: May 28, 2020
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Clinical Study Report will become available approximately 60 to 90 days after last patient last visit. Each Investigator will receive one to keep. Protocol will be received prior to study start for each investigator.
• Access Criteria: Be an active investigator in the TST001-1001 trial

Locations

US (18)