Esophageal Cancer Clinical Trial

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

Summary

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria

Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
Eastern Cooperative Oncology Group Performance Status 0-1
Fresh biopsies may be required
Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol

Additional Specific Inclusion Criteria for Participants with Melanoma

Histologically confirmed, unresectable stage III or stage IV melanoma
Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
Prior treatment with an approved anti-PD-1 or anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1 agent

Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease

Participants with histologically confirmed advanced non-small cell lung cancer
Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
Previously treated with approved PD-L1/PD-1 inhibitors
Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening

Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma

Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
Participants who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling in the study

Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease

Participants with histologically confirmed advanced non-small cell lung cancer
Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening

Exclusion criteria

Pregnancy, lactation, or breastfeeding
Known hypersensitivity to any of the components of RO7247669
Active or untreated central nervous system (CNS) metastases
An active second malignancy
Evidence of concomitant diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Positive HIV, hepatitis B, or hepatitis C test result
Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
Vaccination with live vaccines within 28 days prior to Cycle 1 Day 1
Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
Active or history of autoimmune disease or immune deficiency
Prior treatment with adoptive cell therapies, such as CAR-T therapies
Concurrent therapy with any other investigational drug < 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administration
Regular immunosuppressive therapy
Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy
Prior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitor

Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease

Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK

Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma

Prior therapy with any immunomodulatory agents

Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease

Prior therapy for metastatic disease is not permitted
Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

320

Study ID:

NCT04140500

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 22 Locations for this study

See Locations Near You

Sharp Memorial Hospital
San Diego California, 92123, United States
Henry Ford Hospital; Hematology/Oncology Phase 1
Detroit Michigan, 48202, United States
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø , 2100, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
Hadassah University Hospital - Ein Kerem; Oncology
Jerusaelm , 91120, Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Chaim Sheba medical center, Oncology division
Ramat Gan , 52620, Israel
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 003-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid , 28027, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid , 28040, Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid , 28050, Spain
Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Christie Hospital NHS Trust; Experimental Cancer Medicine Team
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

320

Study ID:

NCT04140500

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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