Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

LianBio

Status and phase: Enrolling; Phase 2

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: Infigratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06206278

LB1001-203

Details and patient eligibility

About

This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older
• Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
• Failed at least 2 lines of prior systemic therapy
• Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
• At least one measurable tumor lesion by RECIST v1.1
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
• Life expectancy ≥3 months.
• Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.

Exclusion criteria

• History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
• Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
• Any known hypersensitivity to infigratinib or its excipients.
• History and/or current evidence of extensive tissue calcification.
• Current evidence of endocrine alterations of calcium/phosphate homeostasis.
• Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.
• Considered unsuitable to participate in the study by Investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Infigratinib

Experimental group

Description:

Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.

Treatment:

Drug: Infigratinib