GEN1046 Safety Trial in Patients With Malignant Solid Tumors
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ClinicalTrials.gov Identifier: NCT03917381 |
Recruitment Status :
Recruiting
First Posted : April 17, 2019
Last Update Posted : January 26, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | April 11, 2019 | ||||||
First Posted Date ICMJE | April 17, 2019 | ||||||
Last Update Posted Date | January 26, 2022 | ||||||
Actual Study Start Date ICMJE | May 14, 2019 | ||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | GEN1046 Safety Trial in Patients With Malignant Solid Tumors | ||||||
Official Title ICMJE | First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors | ||||||
Brief Summary | The purpose of the trial is to evaluate the safety of GEN1046 as monotherapy and in combination therapies in patients with malignant solid tumors | ||||||
Detailed Description | The trial is an open-label, multi-center safety trial of GEN1046. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a)). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: The starting dose is administered as a flat dose. Dose escalation steps are based on safety data Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Arm
GEN1046 Open label, single arm trial where GEN1046 will be administered as monotherapy (or in combination with docetaxel or pembrolizumab in separate expansion cohorts)
Interventions:
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Publications * | Muik A, Garralda E, Altintas I, Gieseke F, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso PM, Alonso G, Rodriguez-Ruiz ME, Schoedel KB, Blum JM, Sänger B, Salcedo TW, Burm SM, Stanganello E, Verzijl D, Vascotto F, Sette A, Quinkhardt J, Plantinga TS, Toker A, van den Brink EN, Fereshteh M, Diken M, Satijn D, Kreiter S, Breij ECW, Bajaj G, Lagkadinou E, Sasser K, Türeci Ö, Forssmann U, Ahmadi T, Şahin U, Jure-Kunkel M, Melero I. Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors. Cancer Discov. 2022 May 2;12(5):1248-1265. doi: 10.1158/2159-8290.CD-21-1345. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
572 | ||||||
Original Estimated Enrollment ICMJE |
192 | ||||||
Estimated Study Completion Date ICMJE | December 2023 | ||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria: For Dose Escalation: • Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy For Expansion: • Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy For two separate expansion cohorts: metastatic NSCLC without prior systemic treatment regimens for metastatic disease. For Both Dose Escalation and Expansion
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Czechia, Hungary, Israel, Italy, Poland, Spain, United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT03917381 | ||||||
Other Study ID Numbers ICMJE | GCT1046-01 2018-003402-63 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Genmab | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Genmab | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | BioNTech SE | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Genmab | ||||||
Verification Date | January 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |