Clinical Trials in Japan / NCT06057038
Active, not recruiting
Phase 1
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
NCT06057038 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Malignant Solid Tumor
Investigational drug(s) / intervention(s)
GEN1042: Intravenous
Pembrolizumab: Intravenous
Cisplatin: Intravenous
Carboplatin: Intravenous
5-Fluorouracil: Intravenous
Study 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.
Eligibility
Key Inclusion Criteria:
1. Must have measurable disease according to RECIST v1.1.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
3. Acceptable organ and bone marrow function.
4. Participant must have a life expectancy of at least 3 months.
Key Exclusion Criteria:
1. Has clinically significant toxicities from previous anticancer therapies.
2. Has rapidly progressing disease.
3. Has a history of noninfectious pneumonitis/interstitial lung disease.
4. Has a history of liver disease.
5. 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.
6. Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
7. Has had major surgery within 4 weeks before Screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
- Number of Participants with Dose Limiting Toxicities (DLTs) — During the first cycle (Cycle length = 21 days)
Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0. - Percentage of Participants with Adverse Events (AEs) — From first dose until the end of the treatment (approximately 3 years)
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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| National Cancer Center East | Kashiwa | Japan | |
| National Cancer Center Hospital | Tokyo | Japan | |
| Tokyo Medical University Hospital | Tokyo | Japan |
On this site
📄 Keytruda (pembrolizumab) drug profile →More Genmab trials in Japan
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06057038 on ClinicalTrials.gov ↗ ← All trials in Japan