NCT06057038

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. The trial consists of 2 parts: a GEN1042 Monotherapy Dose Escalation Part (phase 1a); and a Combination Therapy Part (phase 1b). The purpose of Dose Escalation Part (phase 1a) is to evaluate GEN1042 as monotherapy in participants with non-central nervous system (non-CNS) malignant solid tumors. The Combination Therapy Part (phase 1b) will evaluate GEN1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (SOC) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) and non-small-cell lung cancer (NSCLC).

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	GEN1042	Intravenous
DRUG	Pembrolizumab	Intravenous
DRUG	Cisplatin	Intravenous
DRUG	Carboplatin	Intravenous
DRUG	5-Fluorouracil	Intravenous

Timeline

• Start date: 2023-11-24
• Primary completion: 2026-11-28
• Completion: 2026-11-28
• First posted: 2023-09-28
• Last updated: 2026-04-08

Locations

3 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study