A Phase 1/2 interventional study of TST001 and Nivolumab Injection [Opdivo] in Advanced Cancer, Gastric Cancer and Gastroesophageal-junction Cancer, sponsored by Transcenta Therapeutics (Hangzhou) Co., Ltd.. Active, not recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Transcenta Therapeutics (Hangzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment
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Among 804 studies in Stomach Neoplasms with a site in United States — 157 open to participants now, 239 under way, 12 of them phase 3. Stomach Neoplasms · United States.
Among the 804 studies in Stomach Neoplasms with a site in United States, this one is the 161st largest by planned enrollment of the 686 interventional ones that give a count, is one of 49 that started in 2020, is one of 109 in phase 1/2, reaches primary completion later than 99 of the 238 other live ones, and was the 524th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →157 of the 804 studies in Stomach Neoplasms with a site in United States are open now. Recruiting first, the newest first:
University of Illinois Chicago · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
Sutro Biopharma, Inc. · Sites in United States
Ages 18+
MacroGenics · Sites in United States
Ages 18+
GE Healthcare · Sites in United States, Sweden
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
804 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 380 · Phase 2 338 · Phase 3 45 · Phase 4 10
First in 1992; this study’s year is marked. 49 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 53 across the 686 interventional studies, 207 across the 83 observational. Of the 512 that completed or were terminated, 196 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
381 of 804 have an industry lead sponsor. The 10 most frequent:
Transcenta Therapeutics (Hangzhou) Co., Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Transcenta Therapeutics (Hangzhou) Co., Ltd. has 2 studies filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Stomach Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT07217704Phase 3SOFIEUsing 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. | 2027-08-30 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT05183126University of Michigan Rogel Cancer CenterPharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer | 2026-11 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
Add all 81 to your calendar (.ics) → With an account.
Among the 804 studies in Stomach Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria
Other protocol-defined Inclusion/Exclusion Criteria could apply.
.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.
Drug: TST001
Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.
Drug: TST001
Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.
Drug: TST001 · Drug: Nivolumab Injection [Opdivo] · Drug: mFOLFOX6
Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.
Drug: TST001 · Drug: Nivolumab Injection [Opdivo]
Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.
Drug: TST001 · Drug: Gemcitabine · Drug: Albumin-Bound Paclitaxel
TST001 is a humanized IgG1 monoclonal antibody.
Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies
mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
Chemotherapy medication
Also known as: Gemzar
Chemotherapy medication
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 100 days following last dose
Immunogenicity
by measurement of Incidence of anti-drug antibodies (ADA)
Time frame: up to 30 days following last dose
Objective response rate (ORR)
as measured by RECIST 1.1
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
Duration of Response (DOR)
duration of response (DOR)
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
Progression free survival (PFS)
as measured by RECIST v1.1
Time frame: up to 24 months, until disease progression or start of another anti-cancer therapy
PK parameters
Maximum serum concentration (Cmax)
Time frame: Up to 30 days following last dose
PK
time to reach maximum serum concentration (Tmax)
Time frame: Up to 30 days following last dose
PK
Area Under the Curve
Time frame: Up to 30 days following last dose
Plan to share: Yes — As described below. Patient personal data will be kept confidential as per HIPAA.
Supporting information: Study protocol, Clinical study report
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
No publications or documents are linked to this record.
Started May 2020 (actual). Primary completion is estimated for Jun 2027, 85 months after the start.
Of 89 industry-sponsored phase 1/2 interventional studies under Stomach Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 109. This study's planned 85 months is above that.
Counting every sponsor, half of 156 studies reached it within 60 months; a quarter within 41 and three quarters within 109.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion May 2026 → Jun 2027 and completion Nov 2026 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Osemitamab
Transcenta Therapeutics (Hangzhou) Co., Ltd.