Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer (PILOT)

Astellas

Status and phase: Completed; Phase 1

Conditions: CLDN18.2-positive Gastric Adenocarcinoma; CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction; CLDN18.2-positive Adenocarcinoma of Esophagus

Treatments: Drug: IMAB362; Drug: Interleukin-2 (3 million IU); Drug: Interleukin-2 (1 million IU); Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01671774

2011-005509-64 (EudraCT Number)

GM-IMAB-001-04

Details and patient eligibility

About

The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
• Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
• CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
• Measurable and/or non-measurable disease as defined according to RECIST v1.1
• Age ≥ 18 years
• Written informed consent
• ECOG performance status (PS) 0-1
• Life expectancy > 3 months

Exclusion criteria

• Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
• Known HIV infection or known symptomatic hepatitis (A, B, C)
• Clinical symptoms of cerebral metastases
• Pregnancy or breastfeeding
• Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
• Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL (3.0 mmol/L)

Trial design

29 participants in 4 patient groups

IMAB362 + ZA

Experimental group

Description:

Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.

Treatment:

Drug: Zoledronic acid

Drug: IMAB362

IMAB362 + ZA + IL-2 (1 million IU)

Experimental group

Description:

Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.

Treatment:

Drug: Zoledronic acid

Drug: Interleukin-2 (1 million IU)

Drug: IMAB362

IMAB362 + ZA + IL-2 (3 million IU)

Experimental group

Description:

Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.

Treatment:

Drug: Zoledronic acid

Drug: Interleukin-2 (3 million IU)

Drug: IMAB362

IMAB362

Active Comparator group

Description:

Participants received IMAB362 only on Day 1 of each cycle every 3 weeks.

Treatment:

Drug: IMAB362