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TST001

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 17, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

TST001 · 1 trial · 4 indications

Phase 1 1
NCT04396821A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid TumorsAdvanced Cancer
ACTIVE NOT_RECRUITING150 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Participant Safety as characterized by frequency and severity of adverse events
up to 100 days following last dose

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

Maximum Tolerated Dose (MTD or Recommended Phase 2 Dose (RP2D)
up to 100 days following last dose

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

Participant Safety and Tolerability of TST001 in combination with Nivolumab as characterized by frequency and severity of adverse events
Up to 100 days following last dose

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

Participant Safety and Tolerability of TST001 in combination with Nivolumab and mFOLFOX6 as characterized by frequency and severity of adverse events
Up to 100 days following last dose

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

Participant Safety and Tolerability of TST001 in combination with gemcitabine and albumin-bound paclitaxel as characterized by frequency and severity of adverse events
Up to 100 days following last dose

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A Q2WEXPERIMENTALDosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.
Part A Q3WEXPERIMENTALDosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.
Part B Cohort AEXPERIMENTALPatients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.
Part B Cohort BEXPERIMENTALPatients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.
Part B Cohort CEXPERIMENTALPatients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.

Interventions

NameTypeDescription
TST001DRUGTST001 is a humanized IgG1 monoclonal antibody.
Nivolumab Injection [Opdivo]DRUGNivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies
mFOLFOX6DRUGmFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
GemcitabineDRUGChemotherapy medication
Albumin-Bound PaclitaxelDRUGChemotherapy medication
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * 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 s...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about TST001

What is TST001 used for?

TST001 is an investigational small molecule being developed for the treatment of advanced cancer, including gastric cancer, gastroesophageal-junction cancer, and pancreatic cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes TST001?

TST001 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The drug is currently in Phase 1 clinical trials for advanced cancer.

What phase is TST001 in?

TST001 is in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for advanced or metastatic solid tumors. The drug has not been approved by the FDA and remains in clinical testing.

What clinical trials is TST001 in?

TST001 is being evaluated in a Phase 1 clinical trial with the identifier NCT04396821. This trial is assessing the safety and tolerability of TST001 in patients with advanced or metastatic solid tumors, including gastric, gastroesophageal-junction, and pancreatic cancers. The trial is active but not recruiting participants.

Is TST001 the same as any other drug?

TST001 is a distinct investigational drug candidate developed by Bristol-Myers Squibb. No alternative names for TST001 have been reported in the clinical trial information. It is a small molecule being studied for the treatment of advanced cancer.