MedPath

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Registration Number
NCT02794571
Lead Sponsor
Genentech, Inc.
Brief Summary

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
518
Inclusion Criteria
  • Adults 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Adequate hematologic and end organ function
  • Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
  • Confirmed availability of representative tumor specimens
  • Measurable disease according to RECIST Version 1.1
Exclusion Criteria
  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  • Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
  • Leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
  • History of autoimmune disease
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C, or tuberculosis
  • Severe infection within 4 weeks prior to randomization
  • Prior allogeneic bone marrow or solid organ transplant
  • Significant cardiovascular disease
  • Known clinically significant liver disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Phase Ia Dose-Escalation Stage: TiragolumabTiragolumabCohorts of at least 3 participants each will be treated with escalating doses of tiragolumab.
Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+AtezolizumabTiragolumabA minimum of 3 participants will be treated for each dose level of tiragolumab in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort ATiragolumabIn Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort BTiragolumabIn Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CTiragolumabIn Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort DTiragolumabIn Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.
Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+AtezolizumabTiragolumabParticipants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+AtezolizumabTiragolumabParticipants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag.
Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1TiragolumabIn Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.
Phase Ia Dose-Expansion Stage: TiragolumabTiragolumabParticipants will be treated with tiragolumab at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study.
Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+AtezolizumabAtezolizumabA minimum of 3 participants will be treated for each dose level of tiragolumab in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+AtezolizumabAtezolizumabParticipants will be treated every 3 weeks (Q3W) with tiragolumab at or below the MTD or MAD in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+AtezolizumabTiragolumabParticipants will be treated every 3 weeks (Q3W) with tiragolumab at or below the MTD or MAD in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort AAtezolizumabIn Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort ACarboplatinIn Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort ACisplatinIn Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort BAtezolizumabIn Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort BCarboplatinIn Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort APemetrexedIn Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort BPaclitaxelIn Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CAtezolizumabIn Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CCarboplatinIn Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CCisplatinIn Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CEtoposideIn Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort DAtezolizumabIn Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.
Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+AtezolizumabAtezolizumabParticipants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab.
Phase Ib Chemotherapy Dose-Expansion Stage: Cohort DCapecitabineIn Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.
Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+AtezolizumabAtezolizumabParticipants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag.
Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1AtezolizumabIn Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.
Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1BevacizumabIn Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.
Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2TiragolumabIn Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle.
Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2PembrolizumabIn Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants with Dose-Limiting Toxicities (DLTs)From Baseline to the end of Cycle 1 (up to 21 days)
Number of Cycles with TiragolumabFrom Baseline to last dose (up to approximately 8 years)
Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 8 years)
Phase Ib: Percentage of Participants with ADAs to AtezolizumabDay 1 up to 8 years

Phase 1b (without Chemotherapy): Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, at DC, every 30 days up to 120 days (cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (cycle length 21/28 days).

Phase Ia and Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to TiragolumabDay 1 up to 8 years

Phase (Ph) 1a: Pre-dose on Day 1, Cycles 1-4, 8, 16, every eight cycles (Q8C), at discontinuation (DC), every 30 days up to 120 days (cycle length 21 days); Phase 1b without Chemotherapy: Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, DC (cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (cycle length 21/28 days).

Secondary Outcome Measures
NameTimeMethod
Maximum Serum Concentration (Cmax) of TiragolumabDay 1 up to 8 years

During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.

During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12\* 16 (C12\* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.

Plasma Concentration of CisplatinPre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of CapecitabinePre-dose (5 min) on Day 1 of Cycle 1 and post-dose (2 hours) on Day 1 of Cycle 3 (cycle length 21 days)
Progression-Free Survival (PFS) According to RECIST Version 1.1From Baseline until disease progression (up to 8 years)
Cmin of AtezolizumabDay 1 up to 8 years

During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 hour post-dose; Q8C, DC; every 30 days up to 120 days.

During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles (cycle length 21/28 days) 1-4,8, 12\*, 16 (C12\* only applicable to Q4W and Chemotherapy cohorts); Post-dose 0.5 hour on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days. For Q4W co-infusion cohort only: post-dose Days 2, 8 and 15 of Cycle 1.

Plasma Concentration of EtoposidePre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Duration of Objective Response (DOR) According to RECIST Version 1.1From Baseline until disease progression (up to 8 years)
Overall survival (OS) According to RECIST Version 1.1Baseline until death from any cause (up to approximately 8 years)
Area Under the Concentration-Time Curve (AUC) of TiragolumabDay 1 up to 8 years

During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; Ph1a and 1b - Q8C, DC; every 30 days up to 120 days.

During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12\* 16 (C12\* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.

Minimum Serum Concentration (Cmin) of TiragolumabDay 1 up to 8 years

During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.

During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12\* 16 (C12\* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.

Plasma Concentration of CarboplatinPre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of PemetrexedPre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Volume of Distribution at Steady State (Vss) of TiragolumabDay 1 up to 8 years

During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.

During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12\* 16 (C12\* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.

Cmax of AtezolizumabDay 1 up to 8 years

During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 hour post-dose; Q8C, DC; every 30 days up to 120 days.

During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles (cycle length 21/28 days) 1-4, 8, 12\*, 16 (C12\* only applicable to Q4W and Chemotherapy cohorts); Post-dose 0.5 hour on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days. For Q4W co-infusion cohort only: post-dose Days 2, 8 and 15 of Cycle 1.

Plasma Concentration of PaclitaxelPre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1From Baseline until disease progression (up to 8 years)
Clearance (CL) of TiragolumabDay 1 up to 8 years

During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.

During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12\* 16 (C12\* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.

Trial Locations

Locations (28)

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

🇺🇸

Baltimore, Maryland, United States

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

🇯🇵

Tokyo, Japan

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Honor Health Research Institute

🇺🇸

Scottsdale, Arizona, United States

University of California Los Angeles

🇺🇸

Santa Monica, California, United States

Dana Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Tennessee Oncology - Nashville

🇺🇸

Nashville, Tennessee, United States

Institut Bergonie CLCC Bordeaux

🇫🇷

Bordeaux, France

Kinghorn Cancer Centre; St Vincents Hospital

🇦🇺

Darlinghurst, New South Wales, Australia

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

Peter MacCallum Cancer Center

🇦🇺

North Melbourne, Victoria, Australia

Institut Gustave Roussy

🇫🇷

Villejuif, France

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

🇫🇷

Lyon, France

Institut Claudius Regaud; Departement Oncologie Medicale

🇫🇷

Toulouse, France

Institut Curie

🇫🇷

Paris, France

National Cancer Center Hospital

🇯🇵

Tokyo, Japan

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

ICO L'Hospitalet; Servicio de oncologia medica

🇪🇸

L'Hospitalet de Llobregat, Barcelona, Spain

Clinica Universitaria de Navarra; Servicio de oncología

🇪🇸

Pamplona, Navarra, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

🇪🇸

Sant Andreu de La Barca, Barcelona, Spain

Hospital del Mar

🇪🇸

Barcelona, Spain

Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

🇪🇸

Madrid, Spain

Hospital Clinico Universitario de Valencia

🇪🇸

Valencia, Spain

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Yale Cancer Center

🇺🇸

New Haven, Connecticut, United States

© Copyright 2025. All Rights Reserved by MedPath