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

Last updated: April 7, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

5-Fluorouracil

GEN1042

Pembrolizumab

Clinical Study ID

NCT06057038
GCT1042-03
jRCT2031230438
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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.

Exclusion

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 bonemarrow transplant, or stem cell rescue within 3 months prior to the first dose ofGEN1042.

  6. Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, orprogressive brain metastases or stroke.

  7. Has had major surgery within 4 weeks before Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 42
Treatment Group(s): 5
Primary Treatment: 5-Fluorouracil
Phase: 1
Study Start date:
November 24, 2023
Estimated Completion Date:
December 26, 2026

Study 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).

Connect with a study center

  • Genmab Research Site

    Kashiwa,
    Japan

    Active - Recruiting

  • National Cancer Center East

    Kashiwa,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo,
    Japan

    Active - Recruiting

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