Spots Global Cancer Trial Database for A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
Official Title: An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors
Study ID: NCT03708328
Interventions
Study Description
Brief Summary: This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Columbia Univ Med Ctr, New York, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Leon Berard; Service Oncologie Medicale, Lyon, , France
CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM), Marseille, , France
ICO Rene Gauducheau; CEC, St Herblain, , France
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Auckland City Hospital; Clinical Oncology, Auckland, , New Zealand
Clinica Universitaria de Navarra; Servicio de oncología, Pamplona, Navarra, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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