Clinical trial · Interventional
Study of BAY1834942 in Patients With Solid Tumors
An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Anti-CEACAM6 Antibody BAY1834942 in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced CEACAM6-expressing Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1834942 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Patients with Solid tumors
- 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.
- interventionNames
- Drug: BAY1834942
- type
- EXPERIMENTAL
- label
- Patients with Gastric cancer
- 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.
- interventionNames
- Drug: BAY1834942
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSiu LL, Hong DS, Docke WD, Tetzner R, Trautwein M, Phelps C, Willuda J, Yu XQ, Nogai H, Johnson M, Goh BC. A Phase I Study of the Anti-CEACAM6 Antibody Tinurilimab (BAY 1834942) in Patients with Advanced Solid Tumors. Target Oncol. 2025 Jul;20(4):637-649. doi: 10.1007/s11523-025-01154-4. Epub 2025 Jun 4. PMID 40465170