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
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.
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.
.
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, Csr
No publications or documents are linked to this record.
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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Transcenta Therapeutics (Hangzhou) Co., Ltd.