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Malignant Solid TumorPhase 1NCT06057038

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

A Phase 1 study testing GEN1042, Pembrolizumab and Cisplatin in people with Malignant Solid Tumor, run by Genmab at 3 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumor
What is being tested?
GEN1042, Pembrolizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesJapan
Study dates
24 Nov 2023to Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • National Cancer Center East

    Kashiwa

  • National Cancer Center Hospital

    Tokyo

  • Tokyo Medical University Hospital

    Tokyo

Other trials in Japan

About this study

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

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.

Read the 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).

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06057038
Study groupRoleWhat they receive
Monotherapy (non-CNS Malignant Solid Tumors): GEN1042ExperimentalNot described
Receives: Biological: GEN1042
Combination Therapy Cohort 1 [HNSCC]: GEN1042+Pembro+ChemotherapyExperimentalNot described
Receives: Biological: GEN1042; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: 5-Fluorouracil
Combination Therapy Cohort 2 [HNSCC and NSCLC]: GEN1042+PembroExperimentalNot described
Receives: Biological: GEN1042; Drug: Pembrolizumab
Combination Therapy Cohort 3 [HNSCC]: GEN1042+Pembro+ChemotherapyExperimentalNot described
Receives: Biological: GEN1042; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: 5-Fluorouracil
Combination Therapy Cohort 4 [HNSCC and NSCLC]: GEN1042+PembroExperimentalNot described
Receives: Biological: GEN1042; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.

    Measured: During the first cycle (Cycle length = 21 days)

  2. Percentage of Participants with Adverse Events (AEs)

    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.

    Measured: From first dose until the end of the treatment (approximately 3 years)

Secondary outcomes (8)

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

    Measured: 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

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

  3. Time to Reach Cmax (Tmax) of GEN1042

    Measured: 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

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

    Measured: up to 3 years

  5. Objective Response Rate (ORR)

    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.

    Measured: Up to 3 years

  6. Duration of Response (DOR)

    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.

    Measured: Up to 3 years

  7. Disease Control Rate (DCR)

    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.

    Measured: Up to 3 years

  8. Progression Free Survival (PFS)

    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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start24 Nov 2023
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057038
Sponsor's protocol ID
GCT1042-03
Other IDs
jRCT2031230438
Status last verified
Nov 2026
First submitted
21 Sep 2023
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEN1042, Pembrolizumab and Cisplatin in people with Malignant Solid Tumor, run by Genmab at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: During the first cycle (Cycle length = 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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