Evaluating GEN1042 for Japanese patients 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

This study is testing a new cancer treatment called GEN1042 to see how safe it is and how well it works for Japanese patients with certain solid tumors, both on its own and with other cancer drugs.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genmab (Industry-sponsored)
• Drugs / interventions: pembrolizumab, chemotherapy
• Locations: 3 sites (Kashiwa and 2 other locations)
• Trial ID: NCT06057038 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of GEN1042, both as a standalone treatment and in combination with other anticancer drugs, in Japanese participants with malignant solid tumors. The study is divided into two parts: the first part assesses GEN1042 as monotherapy for non-central nervous system tumors, while the second part examines its effectiveness when combined with pembrolizumab or standard chemotherapy in specific cancer types like head and neck squamous cell carcinoma and non-small-cell lung cancer. The trial aims to gather data on pharmacokinetics, pharmacodynamics, and antitumor activity.

Who should consider this trial

Good fit: Ideal candidates include Japanese adults with measurable malignant solid tumors and an ECOG performance status of 0-1.

Not a fit: Patients with rapidly progressing disease or significant toxicities from prior treatments may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for Japanese patients suffering from malignant solid tumors.

How similar studies have performed: Other studies have shown promise with similar combination therapies, but the specific use of GEN1042 in this context is novel.

Eligibility criteria

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.

Where this trial is running

Kashiwa and 2 other locations

• National Cancer Center East — Kashiwa, Japan (Recruiting)
• National Cancer Center Hospital — Tokyo, Japan (Recruiting)
• Tokyo Medical University Hospital — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Genmab Trial Information

Conditions Malignant Solid Tumor