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A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer

ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstellas Pharma Global Development, Inc.

About this trial

There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe. These conditions are known as advanced or stomach (gastric) cancer and advanced gastroesophageal junction cancer (GEJ cancer for short).

Zolbetuximab is an approved treatment in many countries for people with advanced stomach cancer and advanced GEJ cancer. Some people with these cancers have a protein called Claudin 18.2 on their tumor but they do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative). Zolbetuximab works by attaching to the Claudin 18.2 protein on their tumor. This switches on the body's immune system to attack the tumor.

In India, the standard chemotherapies used are mFOLFOX6 or CAPOX. The main aim of the study is to check the safety of zolbetuximab when given with mFOLFOX6 or CAPOX chemotherapies in people in India with advanced stomach or GEJ cancer. It will also check how well zolbetuximab controls stomach cancer and GEJ cancer when given with mFOLFOX6 or CAPOX.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has histologically confirmed gastric or GEJ adenocarcinoma.

Participant has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to enrollment.

Participant has radiologically evaluable disease (measurable and/or non measurable) according to RECIST 1.1, per investigator assessment, ≤ 28 days prior to enrollment. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before enrollment, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.

Participant has ECOG performance status 0 or 1.

Disqualifiers

Participant has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, mFOLFOX6 or CAPOX.

Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)

Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.

Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zolbetuximab

    Drug

    Participants will receive an IV infusion of zolbetuximab once every 2 or 3 weeks.

  • Oxaliplatin

    Drug

    Participants receiving mFOLFOX6 or CAPOX regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.

  • Folinic Acid

    Drug

    Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of folinic acid once every 2 weeks.

  • 5-fluorouracil

    Drug

    Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion or IV bolus of 5-FU once every 2 weeks.

  • Capecitabine

    Drug

    Participants receiving CAPOX regimen of chemotherapy will receive an oral capecitabine tablet twice daily on Days 1 through 14 and Days 22 through 35 of each cycle.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Zolbetuximab Plus mFOLFOX6 or CAPOXExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

Time frame
Up to 32 months
2

Number of participants with laboratory assessments abnormalities and/or AEs

Number of participants with potentially clinically significant laboratory values.

Time frame
Up to 32 months
3

Number of participants with vital sign abnormalities and/or AEs

Number of participants with potentially clinically significant vital sign values.

Time frame
Up to 32 months
4

Number of Participants at each Eastern Cooperative Oncology Group (ECOG) performance status score

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

Time frame
Up to 29 months

Secondary outcomes

1

Objective response rate (ORR)

Defined as the percentage of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) as investigator assessed per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1).

Time frame
Up to 29 months
2

Duration of response (DOR)

Defined as the time from the date of the first response (CR/PR) until the date of progressive disease (PD) as investigator assessed per RECIST 1.1 or date of death, whichever is earlier.

Time frame
Up to 29 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Astellas Pharma Global Development, Inc.

Lead sponsor

Source ClinicalTrials.gov

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