Advanced CancerPhase 1/2NCT04396821
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing TST001, Nivolumab Injection [Opdivo] and mFOLFOX6 in people with Advanced Cancer and Gastric Cancer, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- TST001, Nivolumab Injection [Opdivo] and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 18 sitesUnited States
- Study dates
- 28 May 2020to 30 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- Other protocol-defined Inclusion/Exclusion Criteria could apply.
- .
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University
Atlanta, Georgia, 30033
NEXT Oncology
Austin, Texas, 78704
Gabrail Cancer Research
Canton, Ohio, 44718
Pennsylvania Cancer Specialist Research Institute
Gettysburg, Pennsylvania, 17325
Banner MD Anderson
Gilbert, Arizona, 85234
University of Kansas, School of Medicine
Kansas City, Kansas, 66160
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt University
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06519
Memorial Sloan Kettering
New York, New York, 10065
Allegheny Hospital
Pittsburgh, Pennsylvania, 15212
Florida Cancer Specialists
Sarasota, Florida, 34232
Swedish Cancer Institute
Seattle, Washington, 98104
Washington University
St Louis, Missouri, 63110
Stony Brook Cancer Center
Stony Brook, New York, 11794
University of Arizona
Tucson, Arizona, 85724
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors
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.
Read the detailed description
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.
18 to 36 participants will be enrolled.
Part B consists of 3 cohorts:
Cohort A is for patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus Nivolumab and mFOLFOX6. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort A.
Cohort B is for patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies. Patient will receive TST001 plus Nivolumab. No selection based on CLDN18.2 expression will be required for the safety run-in (3-6 patients). Patients with CLDN18.2 expression in tumor tissue tested by the central laboratory will be enrolled in the expansion phase. Safety run-in phase will follow 3+3 rule with two dose levels, TST001 3mg/kg and 6mg/kg Q3W combined with nivolumab. Approximately 30 patients will be enrolled in Cohort B including the patients in the safety run-in phase.
Cohort C is for patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus gemcitabine and albumin-bound paclitaxel. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort C.
- Being tested
- TST001, Nivolumab Injection [Opdivo], mFOLFOX6, Gemcitabine, Albumin-Bound Paclitaxel
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TST001Drug
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
mFOLFOX6Drug
mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
GemcitabineDrug
Also called Gemzar
Chemotherapy medication
Albumin-Bound PaclitaxelDrug
Chemotherapy medication
| Study group | Role | What they receive |
|---|---|---|
| Part A Q2W | Experimental | Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested. Receives: 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. Receives: Drug: TST001 |
| Part B Cohort A | Experimental | Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. Receives: 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. Receives: Drug: TST001; Drug: Nivolumab Injection [Opdivo] |
| Part B Cohort C | Experimental | Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma. Receives: Drug: TST001; Drug: Gemcitabine; Drug: Albumin-Bound Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 100 days following last dose
Secondary outcomes (7)
Immunogenicity
by measurement of Incidence of anti-drug antibodies (ADA)
Measured: up to 30 days following last dose
Objective response rate (ORR)
as measured by RECIST 1.1
Measured: up to 24 months, until disease progression or start of another anti-cancer therapy
Duration of Response (DOR)
duration of response (DOR)
Measured: up to 24 months, until disease progression or start of another anti-cancer therapy
Progression free survival (PFS)
as measured by RECIST v1.1
Measured: up to 24 months, until disease progression or start of another anti-cancer therapy
PK parameters
Maximum serum concentration (Cmax)
Measured: Up to 30 days following last dose
PK
time to reach maximum serum concentration (Tmax)
Measured: Up to 30 days following last dose
PK
Area Under the Curve
Measured: Up to 30 days following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start28 May 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part A - 2 arms, Q2w and Q3w, 3+3 design dose escalation; Part B - dose expansion, 3 Cohorts
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Charlie Qi, MD, Study director, Suzhou Transcenta Therapeutics Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396821
- Sponsor's protocol ID
- TST001-1001
- Status last verified
- Nov 2025
- First submitted
- 7 May 2020
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: As described below. Patient personal data will be kept confidential as per HIPAA.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04396821
- Acronym / sponsor ID
- TST001-1001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 28 May 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
18 to 36 participants will be enrolled.
Part B consists of 3 cohorts:
Cohort A is for patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus Nivolumab and mFOLFOX6. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort A.
Cohort B is for patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies. Patient will receive TST001 plus Nivolumab. No selection based on CLDN18.2 expression will be required for the safety run-in (3-6 patients). Patients with CLDN18.2 expression in tumor tissue tested by the central laboratory will be enrolled in the expansion phase. Safety run-in phase will follow 3+3 rule with two dose levels, TST001 3mg/kg and 6mg/kg Q3W combined with nivolumab. Approximately 30 patients will be enrolled in Cohort B including the patients in the safety run-in phase.
Cohort C is for patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus gemcitabine and albumin-bound paclitaxel. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort C.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Part A - 2 arms, Q2w and Q3w, 3+3 design dose escalation; Part B - dose expansion, 3 Cohorts
| Arm | Type | Receives |
|---|---|---|
| Part A Q2W | Experimental | Drug: TST001Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested. |
| Part A Q3W | Experimental | Drug: TST001Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested. |
| Part B Cohort A | Experimental | Drug: TST001, Drug: Nivolumab Injection [Opdivo], Drug: mFOLFOX6Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. |
| Part B Cohort B | Experimental | Drug: TST001, Drug: Nivolumab Injection [Opdivo]Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies. |
| Part B Cohort C | Experimental | Drug: TST001, Drug: Gemcitabine, Drug: Albumin-Bound PaclitaxelPatients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥ 18 years.
- Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.
- Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy.
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TST001TST001 is a humanized IgG1 monoclonal antibody. | Drug | Part A Q2W, Part A Q3W, Part B Cohort A, Part B Cohort B, Part B Cohort C |
| Nivolumab Injection [Opdivo]Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies | Drug | Part B Cohort A, Part B Cohort B |
| mFOLFOX6mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin. | Drug | Part B Cohort A |
| GemcitabineAlso: GemzarChemotherapy medication | Drug | Part B Cohort C |
| Albumin-Bound PaclitaxelChemotherapy medication | Drug | Part B Cohort C |
Primary outcome
Participant Safety as characterized by frequency and severity of adverse events
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Immunogenicity
Time frame: up to 30 days following last dose
Objective response rate (ORR)
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
Duration of Response (DOR)
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
Progression free survival (PFS)
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
PK parameters
Time frame: Up to 30 days following last dose
PK
Time frame: Up to 30 days following last dose
PK
Time frame: Up to 30 days following last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. As described below. Patient personal data will be kept confidential as per HIPAA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Qi, MD study director
Suzhou Transcenta Therapeutics Co.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TST001, Nivolumab Injection [Opdivo] and mFOLFOX6 in people with Advanced Cancer and Gastric Cancer, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Safety as characterized by frequency and severity of adverse events (time frame: up to 100 days following last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.