Study of BAY1834942 in Patients With Solid Tumors

Bayer

Status and phase: Completed; Phase 1

Conditions: Advanced CEACAM6-expressing Solid Tumors

Treatments: Drug: BAY1834942

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596372

18650

2018-002561-19 (EudraCT Number)

Details and patient eligibility

About

This is an open-label, Phase 1, first-in-human, dose escalation and expansion study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody BAY1834942 in patients with advanced solid tumors known to have a prevalence for CEACAM6 expression.

The study consists of dose escalation and a tumor type-specific expansion.

Full description

The primary objectives of the study are to evaluate and characterize the tolerability and safety profile of repeated doses of BAY1834942, and to characterize the pharmacokinetics of BAY1834942 after single dose.

Secondary objectives are to evaluate the tumor response profile, pharmacodynamics, pharmacokinetics and immunogenicity after multiple doses of the drug.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged ≥ 18 years
• Patients with histologically confirmed advanced/ metastatic solid tumors: Dose escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion: advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.
• ECOG-PS of 0 to 1.
• Adequate organ function (bone marrow, liver, kidneys).
• Adequate coagulation function.
• Adequate cardiac function

Exclusion criteria

• Patients with active symptomatic or untreated brain metastases; possible exceptions for patients with treated asymptomatic central nervous system metastases
• Active autoimmune disease
• History or evidence of active pulmonary fibrosis, organizing pneumonia, or pneumonitis.
• Risk factors for bowel obstruction or bowel perforation
• History of cardiac disease
• Uncontrolled arterial hypertension despite optimal medical management
• Clinically relevant findings in electrocardiogram
• HIV infection
• Active HBV or HCV infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Patients with Solid tumors

Experimental group

Description:

Dose escalation with patients having solid tumors. Patients receive escalating doses of BAY1834942 intravenously for 1 hour on Day 1 of each 21-day cycle (Q3W). If the Q3W scheme does not result in sufficient exposure, the scheme is replaced with an once-weekly (QW) dosing scheme.

Treatment:

Drug: BAY1834942

Patients with Gastric cancer

Experimental group

Description:

Expansion with patients having gastric and/or gastroesophageal adenocarcinoma: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.

Treatment:

Drug: BAY1834942

Patients with Colorectal cancer

Experimental group

Description:

Expansion with patients having colorectal cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.

Treatment:

Drug: BAY1834942

Patients with Non-small-cell-lung cancer

Experimental group

Description:

Expansion with patients having adeno Non-small-cell-lung cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.

Treatment:

Drug: BAY1834942

Low-dose expansion

Experimental group

Description:

Expansion with patients having the same cancer type (gastric cancer, or colorectal cancer, or non-small-cell lung cancer) and receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part with a dose lower than the maximum tolerated dose (MTD).

Treatment:

Drug: BAY1834942