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NCT Number: NCT06057038

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center East, Kashiwa, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must have measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Acceptable organ and bone marrow function.
  • Participant must have a life expectancy of at least 3 months.

Key Exclusion Criteria:

  • Has clinically significant toxicities from previous anticancer therapies.
  • Has rapidly progressing disease.
  • Has a history of noninfectious pneumonitis/interstitial lung disease.
  • Has a history of liver disease.
  • 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.
  • Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
  • Has had major surgery within 4 weeks before Screening.

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

Treatment and study plan

GEN1042

Biological

Intravenous

Other names: GEN1042 (DuoBody®-CD40x4-1BB)

Pembrolizumab

Drug

Intravenous

Cisplatin

Drug

Intravenous

carboplatin

Drug

Intravenous

5-fluorouracil

Drug

Intravenous

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: 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.

  2. Percentage of Participants with Adverse Events (AEs)

    Time frame: 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.

Secondary outcomes

  1. Maximum (Peak) Plasma Concentration (Cmax) of GEN1042

    Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)

  2. Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN1042

    Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)

  3. Time to Reach Cmax (Tmax) of GEN1042

    Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)

  4. Number of Participants with Anti-drug Antibodies (ADA) to GEN1042

    Time frame: up to 3 years

    Serum samples will be screened for ADAs binding to GEN1042 and the titer of confirmed positive samples will be reported.

  5. Objective Response Rate (ORR)

    Time frame: Up to 3 years

    ORR is defined as percentage of participants with a best overall response (BOR) (Complete Response (CR) or Partial Response (PR)) confirmed by a subsequent BOR of CR or PR at least 4 weeks later per response evaluation criteria in solid tumors (RECIST) v1.1 based on investigator assessment.

  6. Duration of Response (DOR)

    Time frame: Up to 3 years

    DOR only applies to participants whose confirmed BOR is CR or PR and is defined as time from the first documentation of objective tumor response (CR or PR) to the date of first disease progression (PD) or death per RECIST criteria v1.1 based on investigator assessment.

  7. Disease Control Rate (DCR)

    Time frame: Up to 3 years

    The DCR is defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or Stable Disease (SD) per RECIST criteria v1.1 based on investigator assessment.

  8. Progression Free Survival (PFS)

    Time frame: Up to 3 years

    PFS is defined as the time from Day 1 in Cycle 1 to the first documented progression or death due to any cause per RECIST criteria v1.1 based on investigator assessment.

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Collaborators

  • BioNTech SE

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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