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A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer

ConditionsGastric CancerGastroesophageal-junction Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.

Age: ≥18 and ≤70 years, both male and female.

Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.

Availability of biomarker testing results before enrollment.

Disqualifiers

Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.

20% body weight loss within 2 months before enrollment.

Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.

Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab Injection

    Drug

    Adebrelimab injection.

  • SHR-A1811 for Injection

    Drug

    SHR-A1811 for injection.

  • SHR-A1904 for Injection

    Drug

    SHR-A1904 for injection.

  • SHR-8068 Injection

    Drug

    SHR-8068 injection.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapyExperimental treatment 2 interventions
Group B: Cohort B - Adebrelimab in combination with SHR-A1904Experimental treatment 2 interventions
Group C: Cohort D - Adebrelimab in combination with SHR-8068Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).

Time frame
Approximately 13 weeks.

Secondary outcomes

1

Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0.

Time frame
Approximately 1 year.
2

Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0.

Time frame
Approximately 1 year.
3

Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC).

Time frame
Approximately 13 weeks.
4

Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment.

Time frame
Approximately 13 weeks.

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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