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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006708-34 | EudraCT Number | ||
| 2023-504709-35-00 | EU Trial (CTIS) Number |
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This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia: Dose Escalation | Experimental | Participants in successive cohorts will receive escalating doses of enzelkitug, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
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| Phase Ia: Expansion | Experimental | Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
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| Phase Ib: Dose Escalation | Experimental | Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
|
| Phase Ib: Expansion | Experimental | Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ib dose escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzelkitug | Drug | Enzelkitug will be administered as per the schedule specified in the respective arms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days) | |
| Phase Ib: Number of Participants With DLTs | From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days) | |
| Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 52 months | |
| Phase Ib: Number of Participants With TEAEs | Up to approximately 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug | From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months) | |
| Phase Ia and Phase Ib: Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO43860 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | San Francisco | California | 94305 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Atezolizumab | Drug | Atezolizumab will be administered as per the schedule specified in the respective arms. |
|
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| Pembrolizumab | Drug | Pembrolizumab will be administered as per the schedule specified in the respective arms. |
|
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| From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) |
| Phase Ia and Phase Ib: Duration of Response (DOR) | From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) |
| Phase Ia and Phase Ib: Progression-free Survival (PFS) | From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) |
| Phase Ia and Phase Ib: Percentage of Participants With Anti-drug Antibody (ADA) to Enzelkitug | From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months) |
| University Of Colorado |
| Recruiting |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Florida Cancer Specialists - Sarasota | Recruiting | Sarasota | Florida | 34232 | United States |
| Winship Cancer Institute | Completed | Atlanta | Georgia | 30322 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
| Washington University Medical Center, Division of Oncology | Completed | St Louis | Missouri | 63110 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| The West Clinic - Memphis (Union Ave) | Recruiting | Germantown | Tennessee | 38138 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START | Recruiting | San Antonio | Texas | 78229 | United States |
| Kinghorn Cancer Centre | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Monash Health Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
| Linear Clinical Research Ltd | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| CHU de Liège | Recruiting | Herstal | 4040 | Belgium |
| GasthuisZusters Antwerpen | Recruiting | Wilrijk | 2610 | Belgium |
| British Columbia Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Ottawa Hospital Regional Cancer Centre | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| Sir Mortimer B Davis Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA | Recruiting | Chaïdári | Attica | 124 62 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Recruiting | N. Efkapria-Pavlos Melas | Thessaloniki | 564 03 | Greece |
| Sotiria Thoracic Diseases Hospital of Athens | Recruiting | Athens | 115 27 | Greece |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Recruiting | Amsterdam | 1066 CX | Netherlands |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Asan Medical Center - PPDS | Completed | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Recruiting | Seoul | 06351 | South Korea |
| Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy | Recruiting | Seoul | 120-752 | South Korea |
| ICO l?Hospitalet ? Hospital Duran i Reynals | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Recruiting | Barcelona | 08035 | Spain |
| START MADRID_Hospital Universiario Fundacion Jimenez Diaz | Completed | Madrid | 28040 | Spain |
| Hospital Universitario 12 De Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Sahlgrenska Universitetssjukhuset | Recruiting | Gothenburg | 413 45 | Sweden |
| Karolinska Universitetssjukhuset Solna | Recruiting | Stokholm, Solna | 17176 | Sweden |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| Chung Shan Medical University Hospital | Recruiting | Taichung | 40201 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008545 | Melanoma |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C582435 | pembrolizumab |
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