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SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

ConditionGastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma

No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.

Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;

Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

Disqualifiers

Active leptomeningeal disease or uncontrolled brain metastasis

Diagnosed with gastric or GEJ adenocarcinoma with positive HER2

Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;

Patients with active hepatitis B or hepatitis C;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab will be administered as the protocol described

  • SKB315 for injection

    Drug

    Tislelizumab will be administered as the protocol described

  • Capecitabine

    Drug

    Capecitabine will be taken orally as the protocol described

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: SKB315+TislelizumabExperimental treatment 2 interventions
Group B: SKB315+Tislelizumab+capecitabineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.

Time frame
up to 2 years

Secondary outcomes

1

Duration of Response (DOR)

Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.

Time frame
up to 2 years
2

Progression Free Survival (PFS)

Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Time frame
up to 2 years
3

Overall Survival (OS)

Time from start of treatment to death due to any reason.

Time frame
up to 2 years
4

Safety and tolerability assessed by adverse events (AEs)

An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame
Until 90 days after the end of treatment

Other outcomes

Sponsors and contacts

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

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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