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Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma

ConditionsGastric CancerGastroesophageal-junction CancerAdvanced Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTranscenta Therapeutics (Hangzhou) Co., Ltd.

About this trial

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. ≥18 years of age on day of signing informed consent. 2. Histologically or cytologically confirmed diagnosis of previously untreated, unresectable locally advanced or metastatic G/GEJ adenocarcinoma.

Disqualifiers

Has received any prior systemic anticancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy) for G/GEJ adenocarcinoma. Neo/adjuvant treatment is permitted as long as it was completed at least 6 months prior to randomization.

Has received prior radiotherapy within 2 weeks before randomization; Note: Subjects must have recovered from all radiation-related toxicities. A previously irradiated lesion can be used as measurable lesion as long as it progressed post radiation therapy.

Has received anti-CLDN18.2 agents at any time.

Has received any traditional Chinese medicine or proprietary Chinese medicine with anti-tumor effect within 7 days before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil

    Drug

    TST001 will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

  • Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil

    Drug

    Placebo will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: TST001 + PDL-1 + ChemotherapyActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) based on RECIST (v1.1)

Compare PFS of patients treated with TST001 or Placebo in combination with pembrolizumab and chemotherapy

Time frame
Date of randomization until the date of documented progression or date of death due to any cause, whichever comes first up to 24 months after last dose.

Secondary outcomes

1

Overall Survival (OS) based on RESIST

Compare OS of patients treated with TST001 or Placebo in addition to CapOx or mFOLFOX6 and pembrolizumab or CapOx or mFOLFOX6

Time frame
Time from date of randomization until the date of death due to any cause, assessed up to 24 months after last dose.
2

Overall Response Rate (ORR) based on RESIST (v1.1)

Compare OOR patients treated with TST001 or Placebo in addition to CapOx or mFOLFOX6 and pembrolizumab or CapOx or mFOLFOX6.

Time frame
Date of randomization up to 24 months after last dose
3

Quality of Life (QOL) assessed on EuroQol EQ5D-5L

Change in QOL assessments from baseline of patients treated with TST001 or Placebo in addition to mFOLFOX6 and pembrolizumab or CapOx or mFOLFOX6. Assessments include Cancer QOL questionnaires (QLC-STO22, EQ5D-5L, and QLQ-C30)

Time frame
Date of randomization until the date of documented progression, assessed up to 24 months after last dose
4

Disease Control Rate (DCR) based on RESIST assessed as the percentage of subjects with measurable disease

Compare DCR of patients treated with TST001 or Placebo in addition to CapOx or mFOLFOX6 and pembrolizumab or CapOx or mFOLFOX6.

Time frame
Date of randomization up to 24 months after last dose

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Transcenta Therapeutics (Hangzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: