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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001422-23 | EudraCT Number | ||
| GO27831 | Other Identifier | Hoffmann-La Roche |
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This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort: Atezolizumab 0.01 mg/kg | Experimental | Participants will receive intravenous (IV) infusion of atezolizumab 0.01 milligrams per kilogram (mg/kg) every 3 weeks (q3w) until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 0.03 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 0.03 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 0.1 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 0.1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 0.3 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 0.3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered as IV infusion at eight dose levels (0.01, 0.03, 0.1, 0.3, 1, 3, 10, 20 mg/kg) in dose escalation cohort and at a dose which result in total drug exposure \ |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Day 1 up to Day 21 | |
| Maximum Tolerated Dose (MTD) of Atezolizumab | Day 1 up to Day 21 | |
| Recommended Phase 2 Dose (RP2D) of Atezolizumab | Baseline up to time of determination of MTD (up to Day 21) | |
| Percentage of Participants With Adverse Events | Baseline up to 90 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately [approx] 7 years [yrs]) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) | Predose(0 hour[hr])on Day 1 of Cycles 1,2,4,8,16,17,20(Cycle length=21 days), every 8 cycles thereafter, at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure(up to approx 7 yrs) | |
| Area Under the Concentration-Time Curve (AUC) of Atezolizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Pima Center | Scottsdale | Arizona | 85258 | United States | ||
| The Angeles Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40310568 | Derived | Kondo S, Kitano S, Sato J, Katsuya Y, Kogawa T, Mizugaki H, Miyamoto I, Iwasawa S, Imaizumi T, Tomita H, Murakami C, Miyake T, Yamamoto N. An investigation of extended-interval dosing of atezolizumab in Japanese patients with advanced solid tumors: safety and pharmacokinetics of a dose of 1680 mg every 4 weeks. Invest New Drugs. 2025 Jun;43(3):602-608. doi: 10.1007/s10637-024-01498-0. Epub 2025 May 1. | |
| 33568344 |
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| Dose Escalation Cohort: Atezolizumab 1 mg/kg |
| Experimental |
Participants will receive IV infusion of atezolizumab 1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 3 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 10 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 10 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
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| Dose Escalation Cohort: Atezolizumab 20 mg/kg | Experimental | Participants will receive IV infusion of atezolizumab 20 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. |
|
| Expansion Cohort (Atezolizumab) | Experimental | Participants will receive IV infusion of atezolizumab q3w up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. The dose which result in total drug exposure less than or equal to (\ |
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Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohort: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) |
| Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description) |
| Maximum Serum Concentration (Cmax) of Atezolizumab | Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) | Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description) |
| Minimum Serum Concentration (Cmin) of Atezolizumab | Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) | Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description) |
| Clearance (CL) of Atezolizumab | Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) | Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description) |
| Volume at Steady State (Vss) of Atezolizumab | Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) | Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description) |
| Percentage of Participants With Best Overall Response, Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| Percentage of Participants With Best Overall Response, Assessed by Immune-Related Response Criteria (irRC) | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]), Assessed by RECIST v1.1 | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| Percentage of Participants With Objective Response (CR or PR), Assessed by irRC | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| Duration of Objective Response, Assessed by RECIST v1.1 | Time from the first occurrence of a documented objective response to the time of relapse or death from any cause (up to approx 7 yrs) |
| Duration of Objective Response, Assessed by irRC | Time from the first occurrence of a documented objective response to the time of relapse or death from any cause (up to approx 7 yrs) |
| Progression-Free Survival (PFS), Assessed by RECIST v1.1 | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| PFS, Assessed by irRC | From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs) |
| Los Angeles |
| California |
| 90025 |
| United States |
| Stanford Univ Medical Center; Dept Central Pharmacy | Stanford | California | 94305 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33647 | United States |
| Uni of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins Univ Med Center | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Carolina BioOncology Institute; Can Therapy & Res Ctr | Huntersville | North Carolina | 28078 | United States |
| Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Centre Leon Berard | Lyon | 69008 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Institut Gustave Roussy; Drct | Villejuif | 94805 | France |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Barts & London School of Med; Medical Oncology | London | EC1A 7BE | United Kingdom |
| Derived |
| Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE 3rd, Mariathasan S, O'Hear C, Narayanan S, Fasso M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. Clin Cancer Res. 2021 Jun 15;27(12):3360-3369. doi: 10.1158/1078-0432.CCR-20-1981. Epub 2021 Feb 10. |
| 33241650 | Derived | Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. |
| 32586767 | Derived | Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fasso M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clin Lung Cancer. 2020 Sep;21(5):455-463.e4. doi: 10.1016/j.cllc.2020.05.008. Epub 2020 May 12. |
| 31647026 | Derived | Molinero L, Li Y, Chang CW, Maund S, Berg M, Harrison J, Fasso M, O'Hear C, Hegde P, Emens LA. Tumor immune microenvironment and genomic evolution in a patient with metastatic triple negative breast cancer and a complete response to atezolizumab. J Immunother Cancer. 2019 Oct 23;7(1):274. doi: 10.1186/s40425-019-0740-8. |
| 31542806 | Derived | Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21. |
| 31358540 | Derived | Hamid O, Molinero L, Bolen CR, Sosman JA, Munoz-Couselo E, Kluger HM, McDermott DF, Powderly JD, Sarkar I, Ballinger M, Fasso M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clin Cancer Res. 2019 Oct 15;25(20):6061-6072. doi: 10.1158/1078-0432.CCR-18-3488. Epub 2019 Jul 29. |
| 31204078 | Derived | Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fasso M, O'Hear C, Lin YG, Emens LA. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol. 2019 Aug;154(2):314-322. doi: 10.1016/j.ygyno.2019.05.021. Epub 2019 Jun 14. |
| 30242306 | Derived | Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fasso M, Molinero L, Schmid P. Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study. JAMA Oncol. 2019 Jan 1;5(1):74-82. doi: 10.1001/jamaoncol.2018.4224. |
| 30219915 | Derived | Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fasso M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411. |
| 30077125 | Derived | Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fasso M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. Eur J Cancer. 2018 Sep;101:201-209. doi: 10.1016/j.ejca.2018.06.031. Epub 2018 Aug 1. |
| 30073642 | Derived | Lukas RV, Rodon J, Becker K, Wong ET, Shih K, Touat M, Fasso M, Osborne S, Molinero L, O'Hear C, Grossman W, Baehring J. Clinical activity and safety of atezolizumab in patients with recurrent glioblastoma. J Neurooncol. 2018 Nov;140(2):317-328. doi: 10.1007/s11060-018-2955-9. Epub 2018 Aug 2. |
| 29423515 | Derived | Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fasso M, O'Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncol. 2018 Apr 1;4(4):537-544. doi: 10.1001/jamaoncol.2017.5440. |
| 26755520 | Derived | McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fasso M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11. |
| 25428504 | Derived | Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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