A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
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ClinicalTrials.gov Identifier: NCT05435339 |
Recruitment Status :
Active, not recruiting
First Posted : June 28, 2022
Last Update Posted : May 7, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | June 23, 2022 | ||||
First Posted Date ICMJE | June 28, 2022 | ||||
Last Update Posted Date | May 7, 2024 | ||||
Actual Study Start Date ICMJE | October 4, 2022 | ||||
Estimated Primary Completion Date | September 1, 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy | ||||
Official Title ICMJE | First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors | ||||
Brief Summary | The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion"). |
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Detailed Description | The trial is a First in Human open-label, multicenter, multinational safety trial in participants with non-central nervous system (non-CNS) metastatic or advanced malignant solid tumors for whom there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053. The trial will be conducted as follows:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Sequential assignment Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumor, Adult | ||||
Intervention ICMJE | Biological: GEN1053
GEN1053 will be administered as an intravenous (IV) infusion every 3rd week. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
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Study Arms ICMJE | Experimental: GEN1053 Monotherapy
Intervention: Biological: GEN1053
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Publications * | Not Provided | ||||
* 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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
103 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2026 | ||||
Estimated Primary Completion Date | September 1, 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria: For both the Dose Escalation and Expansion parts:
Bone marrow / hematological function:
Liver function:
Coagulation status:
For Monotherapy Dose Escalation (phase 1) only:
For the Expansion part Only: •Subjects with histologically or cytologically confirmed diagnosis of recurrent, unresectable or metastatic HNSCC, who have progressed on standard of care therapy or do not have any further available standard therapy or are not candidates for or refuse standard therapy (if subjects had access), and for whom experimental therapy with GEN1053 may be beneficial in the opinion of the investigator. Key Exclusion Criteria (all parts):
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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05435339 | ||||
Other Study ID Numbers ICMJE | GCT1053-01 2021-006692-42 ( EudraCT Number ) 1005700 ( Other Identifier: IRAS ID; UK Research Summaries Database ) 2022-502419-12-00 ( EU Trial (CTIS) Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |