Status:
ACTIVE_NOT_RECRUITING
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
Lead Sponsor:
Genmab
Collaborating Sponsors:
BioNTech SE
Conditions:
Malignant Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 part...
Detailed Description
This is an open-label, trial to evaluate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1042 in Japanese participants with malignant solid tumors. T...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06057038
Start Date
November 24 2023
End Date
November 28 2026
Last Update
January 6 2026
Active Locations (3)
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1
National Cancer Center East
Kashiwa, Japan
2
National Cancer Center Hospital
Tokyo, Japan
3
Tokyo Medical University Hospital
Tokyo, Japan