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ACTIVE NOT RECRUITING
NCT06057038
PHASE1

A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

Sponsor: Genmab

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-11-24

Completion Date

2026-11-28

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

GEN1042

Intravenous

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

5-Fluorouracil

Intravenous

Locations (3)

National Cancer Center East

Kashiwa, Japan

National Cancer Center Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan