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Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290, A Fibroblast Activation Protein-A (FAP) Targeted 4-1BB Ligand (CD137L), In Combination With Cibisatamab With Obinutuzumab Pre-Treatment, In Participants With Previously Treated, Metastatic, Microsatellite-stable Colorectal Adenocarcinoma With High CEACAM5 Expression

NCT04826003•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, Phase Ib study to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) in the weekly (QW) and/or every 3 weeks (Q3W) regimens, safety, tolerability, PK, immunogenicity, PD profile and to evaluate preliminary anti-tumor activity of RO7122290 in combination with cibisatamab Q3W after pretreatment with obinutuzumab, in participants with previously treated metastatic, microsatellite-stable colorectal adenocarcinoma with high CEACAM5 expression

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed adenocarcinoma originating from the colon or rectum.
•Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7) not amenable to local treatment.
•Tumors that are MSS (microsatellite-stable) or MSI-low (microsatellite instable low), as determined by a certified laboratory
•Participants with tumors that have high CEACAM5 expression as determined by qRT-PCR in an archival tumor sample or if not available, in a fresh tumor biopsy and documented through central testing of a representative tumor tissue specimen performed at baseline
•Experienced disease progression during or within 3 months following the last administration of approved standard therapies.
•Eastern Cooperative Oncology Group Performance Status of 0 or 1.
•Life expectancy of ≥12 weeks
•Adequate organ functions.
•Serum creatinine within normal limits or a calculated glomerular filtration rate of ≥ 60 mL/min/1.73 m2 for participants with serum creatinine levels above or below the institutional normal value.
•Serum albumin ≥30 g/L (3.0 g/dL).
+2 more criteria

Exclusion Criteria

•Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
•History of leptomeningeal disease
•Non-irradiated tumor lesions \> 2 cm at critical sites (e.g., paraspinal, paratracheal, mediastinal, precarnial, sub-glottal) where tumor swelling induced by cibisatamab is expected to lead to significant complications. Irradiation must be completed at least 14 days prior to initiation of study treatment.
•Dyspnea or peripheral capillary oxygen saturation \< 92% at rest at baseline for patients with bilateral lung lesions or metastases in the remaining lung following lobectomy or pneumonectomy
•Pleural effusion requiring drainage procedures.
•Pleural effusion and/or pleural lesions involving both lungs
•Active interstitial lung disease (ILD), pneumonitis, or a history of ILD/pneumonitis requiring treatment with steroids or history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
•History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
•Patients with \> 10 bilateral pulmonary lesions
+30 more criteria

Locations (13)

Rigshospitalet

København Ø, Denmark

NKI/AvL

Amsterdam, Netherlands

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital del Mar

Barcelona, Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Clinica Universidad de Navarra Madrid

Madrid, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Key Dates

Start Date

July 14, 2021

Primary Completion Date

November 11, 2024

Completion Date

November 11, 2024

Last Updated

July 14, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

RO7122290

DRUG

Cibisatamab

DRUG

Obinutuzumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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