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Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

ConditionsAdvanced Biliary Tract CancerMetastatic Biliary Tract Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMidhun Malla

About this trial

Subjects will receive zolbetuximab with either CAPOX every 3 weeks or mFOLFOX6 every 2 weeks. The chemotherapy regimen chosen, mFOLFOX6 or CAPOX is per the treating investigator discretion and subject preference.

Study treatment will continue for a maximum of 2 years, or until disease progression per RECIST 1.1, intolerable side effects, or investigator/subject preference. Disease evaluation will occur every 8 to 9 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of informed consent.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at the time of registration.

Histological or cytological confirmation of biliary tract carcinoma per American Joint Committee on Cancer (AJCC) staging manual v8.

Radiologically confirmed locally advanced/unresectable (per treating investigator) or metastatic disease.

Disqualifiers

Receipt of 5-fluorouracil or capecitabine in the adjuvant setting within 6 months prior to registration or patients who progressed on FOLFOX or CAPOX regimens in the past.

Previous treatment with Claudin 18.2 directed treatment.

Active infection requiring systemic therapy. NOTE: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the subject is being treated on study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zolbetuximab

    Drug

    Zolbetuximab (800 mg/m\^2) will be administered with CAPOX or mFOLFOX6 for Cycle 1. When administered with CAPOX, for every subsequent cycle Zolbetuximab (600 mg/m\^2) will be administered. When administered with mFOLFOX6, for every subsequent cycle Zolbetuximab (400 mg/m\^2).

  • mFOLFOX6

    Drug

    Oxaliplatin (85 mg/m\^2), Leucovorin (400 mg/m\^2), and 5-FU (5-fluorouracil) continuous infusion (2400 mg/m\^2) will be administered every 2 weeks.

  • CAPOX

    Drug

    Oxaliplatin (130 mg/m\^2) and Capecitabine (750-800 mg/m\^2) will be administered every 3 weeks.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Zolbetuximab and CAPOX or mFOLFOX6Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) rate

PFS will be defined as the percentage of evaluable patients alive and progression-free (radiologically per RECIST 1.1 or clinically per treating investigator discretion) at 6 months from date of registration.

Time frame
6 months

Secondary outcomes

1

Median Progression Free Survival (PFS)

Median PFS is defined as time from registration to date of radiological (per RECIST 1.1) or clinical (per treating investigator discretion) progression or death from any cause, whichever comes first.

Time frame
24 months
2

Overall Survival (OS)

• OS will be defined as time from registration to either date of death due to any cause or last follow-up date.

Time frame
24 months
3

Objective Response Rate (ORR)

ORR is defined as the proportion of subjects, in the evaluable population, who achieve a complete or partial response (CR or PR), per RECIST v 1.1.

Time frame
24 months
4

Disease Control Rate (DCR)

DCR is defined as the proportion of subjects, in the evaluable population, who achieve a complete or partial response (CR or PR), or stable disease (SD) per RECIST v1.1.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Midhun Malla

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

University of Alabama at Birmingham

Collaborator

Astellas Pharma Inc

Collaborator

University of Michigan

Collaborator

Source ClinicalTrials.gov

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