Trial Title:
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
NCT ID:
NCT04140500
Condition:
Solid Tumors
Metastatic Melanoma
Non-small Cell Lung Cancer
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7247669
Description:
Participants will receive intravenous (IV) RO7247669 at different doses either every 2
weeks (Q2W) or every 3 weeks (Q3W)
Arm group label:
Part A: Single-Agent Dose Escalation
Arm group label:
Part B: Tumor Specific Expansion Cohorts
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.
Criteria for 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-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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet; Fase 1 Enhed - Onkologi
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Facility:
Name:
Odense Universitetshospital, Onkologisk Afdeling R
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Facility:
Name:
LLC Arensia Explorer Medicine
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Facility:
Name:
Hadassah University Hospital - Ein Kerem; Oncology
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Facility:
Name:
Rabin MC; Davidof Center - Oncology Institute
Address:
City:
Petach Tikva
Zip:
4941492
Country:
Israel
Facility:
Name:
Chaim Sheba medical center, Oncology division
Address:
City:
Ramat Gan
Zip:
5262000
Country:
Israel
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
463-707
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Hospital Civil de Guadalajara Fray Antonio Alcalde
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Facility:
Name:
Inst. Nacional de Cancerología; Pneumology
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Facility:
Name:
Consultorio Médico Jordi Guzmán Casta
Address:
City:
Querétaro
Zip:
76226
Country:
Mexico
Facility:
Name:
The Institute of Oncology, ARENSIA Exploratory Medicine
Address:
City:
Chisinau
Zip:
MD-2025
Country:
Moldova, Republic of
Facility:
Name:
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Facility:
Name:
National Cancer Centre; Medical Oncology
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Facility:
Name:
Clinica Universitaria de Navarra; Servicio de Oncologia
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Facility:
Name:
Hospital del Mar; Servicio de Oncologia
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Facility:
Name:
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Facility:
Name:
Adana City Hospital, Medical Oncology
Address:
City:
Adana
Zip:
01060
Country:
Turkey
Facility:
Name:
Ankara City Hospital; Oncology
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Address:
City:
Sihhiye/Ankara
Zip:
06230
Country:
Turkey
Facility:
Name:
Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center
Address:
City:
Yen?mahalle
Zip:
06200
Country:
Turkey
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Facility:
Name:
Christie Hospital NHS Trust; Experimental Cancer Medicine Team
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Start date:
November 11, 2019
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04140500
