A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
A Phase 1 Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GEN1042 Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Japanese Subjects With Malignant Solid Tumors
2 other identifiers
interventional
42
1 country
3
Brief Summary
This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
November 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 28, 2026
May 5, 2026
May 1, 2026
3 years
September 21, 2023
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with Dose Limiting Toxicities (DLTs)
Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.
During the first cycle (Cycle length = 21 days)
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
From first dose until the end of the treatment (approximately 3 years)
Secondary Outcomes (8)
Maximum (Peak) Plasma Concentration (Cmax) of GEN1042
Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN1042
Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Time to Reach Cmax (Tmax) of GEN1042
Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Number of Participants with Anti-drug Antibodies (ADA) to GEN1042
up to 3 years
Objective Response Rate (ORR)
Up to 3 years
- +3 more secondary outcomes
Study Arms (5)
Monotherapy (non-CNS Malignant Solid Tumors): GEN1042
EXPERIMENTALCombination Therapy Cohort 1 [HNSCC]: GEN1042+Pembro+Chemotherapy
EXPERIMENTALCombination Therapy Cohort 2 [HNSCC and NSCLC]: GEN1042+Pembro
EXPERIMENTALCombination Therapy Cohort 3 [HNSCC]: GEN1042+Pembro+Chemotherapy
EXPERIMENTALCombination Therapy Cohort 4 [HNSCC and NSCLC]: GEN1042+Pembro
EXPERIMENTALInterventions
Intravenous
Intravenous
Intravenous
Intravenous
Intravenous
Eligibility Criteria
You may qualify if:
- Must have measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Acceptable organ and bone marrow function.
- Participant must have a life expectancy of at least 3 months.
You may not qualify if:
- Has clinically significant toxicities from previous anticancer therapies.
- Has rapidly progressing disease.
- Has a history of noninfectious pneumonitis/interstitial lung disease.
- Has a history of liver disease.
- Has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
- Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
- Has had major surgery within 4 weeks before Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
- BioNTech SEcollaborator
Study Sites (3)
National Cancer Center East
Kashiwa, Japan
National Cancer Center Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Official
Genmab
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
November 24, 2023
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
November 28, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share