Advanced/Metastatic TumorsPhase 1NCT02794571
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
A Phase 1 study testing Atezolizumab, Tiragolumab and Carboplatin in people with Advanced/Metastatic Tumors, run by Genentech, Inc. at 28 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Tumors
- What is being tested?
- Atezolizumab, Tiragolumab and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 23 May 2016to 13 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States8 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Henry Ford Hospital
Detroit, Michigan, 48202
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06520
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of California Los Angeles
Santa Monica, California, 90404
Honor Health Research Institute
Scottsdale, Arizona, 85258
Spain6 sites
Hospital del Mar
Barcelona, 08003
ICO L'Hospitalet; Servicio de oncologia medica
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
Madrid, 28050
Clinica Universitaria de Navarra; Servicio de oncología
Pamplona, Navarre, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, 08740
Hospital Clinico Universitario de Valencia
Valencia, 46010
France5 sites
Institut Bergonie CLCC Bordeaux
Bordeaux, 33000
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, 69008
Institut Curie
Paris, 75005
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Australia2 sites
Kinghorn Cancer Centre; St Vincents Hospital
Darlinghurst, New South Wales, 2010
Peter MacCallum Cancer Center
North Melbourne, Victoria, 3051
Japan2 sites
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, 135-8550
About this study
Official title: A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors
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.
- Conditions
- Advanced/Metastatic Tumors
- Being tested
- Atezolizumab, Tiragolumab, Carboplatin, Cisplatin, Pemetrexed
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called MPDL3280A, RO5541267, Tecentriq
Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle.
TiragolumabDrug
Also called MTIG7192A, RO7092284
Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and/or other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and/or other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit.
CarboplatinDrug
Carboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion.
CisplatinDrug
Cisplatin 75 milligram per square meter (mg/m^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
PemetrexedDrug
Pemetrexed 500 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab.
PaclitaxelDrug
Paclitaxel 200 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab.
EtoposideDrug
Etoposide 100 mg/m^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab.
CapecitabineDrug
Capecitabine 1250 mg/m^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.
BevacizumabDrug
Bevacizumab 15 mg/kg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
PembrolizumabDrug
Pembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia Dose-Escalation Stage: Tiragolumab | Experimental | Cohorts of at least 3 participants each will be treated with escalating doses of tiragolumab. Receives: Drug: Tiragolumab |
| Phase Ia Dose-Expansion Stage: Tiragolumab | Experimental | Participants will be treated with tiragolumab at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study. Receives: Drug: Tiragolumab |
| Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab | Experimental | A 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. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab | Experimental | Participants 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. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A | Experimental | In 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. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed |
| Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B | Experimental | In 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). Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Carboplatin; Drug: Paclitaxel |
| Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C | Experimental | In 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. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide |
| Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D | Experimental | In Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Capecitabine |
| Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab | Experimental | Participants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab | Experimental | Participants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1 | Experimental | In Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Bevacizumab |
| Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2 | Experimental | In Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle. Receives: Drug: Tiragolumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Measured: From Baseline to the end of Cycle 1 (up to 21 days)
Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Measured: From 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)
Number of Cycles with Tiragolumab
Measured: From Baseline to last dose (up to approximately 8 years)
Phase Ia and Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Tiragolumab
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).
Measured: Day 1 up to 8 years
Phase Ib: Percentage of Participants with ADAs to Atezolizumab
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).
Measured: Day 1 up to 8 years
Secondary outcomes (17)
Area Under the Concentration-Time Curve (AUC) of Tiragolumab
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.
Measured: Day 1 up to 8 years
Maximum Serum Concentration (Cmax) of Tiragolumab
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.
Measured: Day 1 up to 8 years
Minimum Serum Concentration (Cmin) of Tiragolumab
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.
Measured: Day 1 up to 8 years
Clearance (CL) of Tiragolumab
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.
Measured: Day 1 up to 8 years
Volume of Distribution at Steady State (Vss) of Tiragolumab
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.
Measured: Day 1 up to 8 years
Cmax of Atezolizumab
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.
Measured: Day 1 up to 8 years
Cmin of Atezolizumab
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.
Measured: Day 1 up to 8 years
Plasma Concentration of Cisplatin
Measured: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Carboplatin
Measured: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Pemetrexed
Measured: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Paclitaxel
Measured: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Etoposide
Measured: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Capecitabine
Measured: Pre-dose (5 min) on Day 1 of Cycle 1 and post-dose (2 hours) on Day 1 of Cycle 3 (cycle length 21 days)
Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: From Baseline until disease progression (up to 8 years)
Duration of Objective Response (DOR) According to RECIST Version 1.1
Measured: From Baseline until disease progression (up to 8 years)
Progression-Free Survival (PFS) According to RECIST Version 1.1
Measured: From Baseline until disease progression (up to 8 years)
Overall survival (OS) According to RECIST Version 1.1
Measured: Baseline until death from any cause (up to approximately 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start23 May 2016
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic TumorsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794571
- Sponsor's protocol ID
- GO30103
- Other IDs
- 2016-000944-33, 2016
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2016
- Last updated
- 5 Dec 2024
- Results posted
- No
Publications
Shemesh CS, Wang Y, An A, Ding H, Chan P, Liu Q, Chen YW, Wu B, Wu Q, Wang X. Phase I pharmacokinetic, safety, and preliminary efficacy study of tiragolumab in combination with atezolizumab in Chinese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2024 Jul;94(1):45-55. doi: 10.1007/s00280-024-04650-y. Epub 2024 Mar 7.
PubMed 38451273Garralda E, Oh DY, Italiano A, Bedard PL, Delord JP, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez-Vida A, Shemesh CS, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho BC, Kim TW, Wu B. Pharmacokinetics (PK) of Tiragolumab in First-in-Human Study in Patients with Mixed Solid Tumors (GO30103). J Clin Pharmacol. 2024 May;64(5):544-554. doi: 10.1002/jcph.2397. Epub 2024 Jan 17.
PubMed 38105505Kim TW, Bedard PL, LoRusso P, Gordon MS, Bendell J, Oh DY, Ahn MJ, Garralda E, D'Angelo SP, Desai J, Hodi FS, Wainberg Z, Delord JP, Cassier PA, Cervantes A, Gil-Martin M, Wu B, Patil NS, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho BC. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors: A Phase 1a/1b Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1574-1582. doi: 10.1001/jamaoncol.2023.3867.
PubMed 37768658
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors
- ClinicalTrials.gov ID
- NCT02794571
- Acronym / sponsor ID
- GO30103
- Conditions
- Advanced/Metastatic Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phase Ia Dose-Escalation Stage: Tiragolumab | Experimental | Drug: TiragolumabCohorts of at least 3 participants each will be treated with escalating doses of tiragolumab. |
| Phase Ia Dose-Expansion Stage: Tiragolumab | Experimental | Drug: TiragolumabParticipants 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+Atezolizumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabA 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+Atezolizumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants 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 A | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: Carboplatin, Drug: Cisplatin, Drug: PemetrexedIn 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 B | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: Carboplatin, Drug: PaclitaxelIn 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 C | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: Carboplatin, Drug: Cisplatin, Drug: EtoposideIn 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 D | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: CapecitabineIn 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+Atezolizumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants 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+Atezolizumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants 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 NC1 | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: BevacizumabIn 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 NC2 | Experimental | Drug: Tiragolumab, Drug: PembrolizumabIn Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: MPDL3280A, RO5541267, TecentriqAtezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D, Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1, Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab, Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab, Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab, Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab |
| TiragolumabAlso: MTIG7192A, RO7092284Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and/or other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and/or other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit. | Drug | Phase Ia Dose-Escalation Stage: Tiragolumab, Phase Ia Dose-Expansion Stage: Tiragolumab, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D, Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1, Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2, Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab, Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab, Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab, Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab |
| CarboplatinCarboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C |
| CisplatinCisplatin 75 milligram per square meter (mg/m^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C |
| PemetrexedPemetrexed 500 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A |
| PaclitaxelPaclitaxel 200 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B |
| EtoposideEtoposide 100 mg/m^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C |
| CapecitabineCapecitabine 1250 mg/m^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion. | Drug | Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D |
| BevacizumabBevacizumab 15 mg/kg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab. | Drug | Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1 |
| PembrolizumabPembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab. | Drug | Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2 |
Primary outcome
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Baseline to the end of Cycle 1 (up to 21 days)
Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Time frame: From 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)
Number of Cycles with Tiragolumab
Time frame: From Baseline to last dose (up to approximately 8 years)
Phase Ia and Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Tiragolumab
Time frame: Day 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).
Phase Ib: Percentage of Participants with ADAs to Atezolizumab
Time frame: Day 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).
17 secondary outcomes
Area Under the Concentration-Time Curve (AUC) of Tiragolumab
Time frame: Day 1 up to 8 years
Maximum Serum Concentration (Cmax) of Tiragolumab
Time frame: Day 1 up to 8 years
Minimum Serum Concentration (Cmin) of Tiragolumab
Time frame: Day 1 up to 8 years
Clearance (CL) of Tiragolumab
Time frame: Day 1 up to 8 years
Volume of Distribution at Steady State (Vss) of Tiragolumab
Time frame: Day 1 up to 8 years
Cmax of Atezolizumab
Time frame: Day 1 up to 8 years
Cmin of Atezolizumab
Time frame: Day 1 up to 8 years
Plasma Concentration of Cisplatin
Time frame: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Carboplatin
Time frame: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Pemetrexed
Time frame: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Paclitaxel
Time frame: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Etoposide
Time frame: Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
Plasma Concentration of Capecitabine
Time frame: Pre-dose (5 min) on Day 1 of Cycle 1 and post-dose (2 hours) on Day 1 of Cycle 3 (cycle length 21 days)
Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From Baseline until disease progression (up to 8 years)
Duration of Objective Response (DOR) According to RECIST Version 1.1
Time frame: From Baseline until disease progression (up to 8 years)
Progression-Free Survival (PFS) According to RECIST Version 1.1
Time frame: From Baseline until disease progression (up to 8 years)
Overall survival (OS) According to RECIST Version 1.1
Time frame: Baseline until death from any cause (up to approximately 8 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 38451273Shemesh CS, Wang Y, An A, Ding H, Chan P, Liu Q, Chen YW, Wu B, Wu Q, Wang X. Phase I pharmacokinetic, safety, and preliminary efficacy study of tiragolumab in combination with atezolizumab in Chinese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2024 Jul;94(1):45-55. doi: 10.1007/s00280-024-04650-y. Epub 2024 Mar 7.
- Derived from this study: PubMed 38105505Garralda E, Oh DY, Italiano A, Bedard PL, Delord JP, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez-Vida A, Shemesh CS, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho BC, Kim TW, Wu B. Pharmacokinetics (PK) of Tiragolumab in First-in-Human Study in Patients with Mixed Solid Tumors (GO30103). J Clin Pharmacol. 2024 May;64(5):544-554. doi: 10.1002/jcph.2397. Epub 2024 Jan 17.
- Derived from this study: PubMed 37768658Kim TW, Bedard PL, LoRusso P, Gordon MS, Bendell J, Oh DY, Ahn MJ, Garralda E, D'Angelo SP, Desai J, Hodi FS, Wainberg Z, Delord JP, Cassier PA, Cervantes A, Gil-Martin M, Wu B, Patil NS, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho BC. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors: A Phase 1a/1b Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1574-1582. doi: 10.1001/jamaoncol.2023.3867.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atezolizumab, Tiragolumab and Carboplatin in people with Advanced/Metastatic Tumors, run by Genentech, Inc. at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, France, South Korea, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: From Baseline to the end of Cycle 1 (up to 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794571, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.