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Advanced Malignant Solid TumorsPhase 1NCT06573294

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors

A Phase 1 study testing GEN1057 and Premedication in people with Advanced Malignant Solid Tumors and Metastatic Malignant Solid Tumors, run by Genmab at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer. Trial details include: The trial duration for an individual participant will be up to approximately 11 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEN1057 and Premedication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
5 sitesin 3 countries
Study dates
28 Aug 2024to 7 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Advanced and/or metastatic malignant solid tumors, who have progressed on standard of care therapy for whom there is no available standard therapy likely to provide clinical benefit, or who are not candidates for available therapy, and for whom experimental therapy with GEN1057 may be beneficial, in the opinion of the investigator.
  • Be at least 18 (or the legal age of consent in the jurisdiction in which the trial is taking place) years of age.
  • Have measurable disease according to RECIST v1.1.
  • Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at screening and on C1D1 pretreatment. Note: If screening ECOG PS is assessed within 3 days prior to C1D1, ECOG PS does not need to be reassessed at C1D1.
  • Have a life expectancy of ≥3 months.

Who cannot join

  • Has been exposed to any of the following prior therapies/treatments within the specified timeframes:
  • Treatment with an investigational anticancer agent within 28 days or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
  • Treatment with an investigational drug, including investigational vaccines within 28 days before the planned first dose of trial treatment.
  • Prior treatment with live, attenuated vaccines within 28 days prior to initiation of GEN1057. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live, attenuated vaccines and are not allowed. Experimental and/or nonauthorized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations are not allowed.
  • Used an invasive investigational medical device within 28 days before the planned first dose of trial treatment.
  • Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ grade 2. There is no limitation for alopecia and hearing impairment from previous therapies.
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  • Has known, symptomatic brain metastases. Asymptomatic brain metastases are allowed provided that they have been treated, have been stable for >28 days as documented by radiographic imaging, and do not require prolonged (>14 days) systemic corticosteroid therapy.
  • Has a past or current malignancy other than inclusion diagnosis.
  • Note: Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States2 sites

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

Other trials in United States

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Start Madrid Centro Integral Oncologico Clara Campal CIOCC

    Madrid, 28050

Other trials in Spain

Japan1 site

  • National Cancer Center, Tsukiji 5-1-1

    Tokyo

Other trials in Japan

About this study

Official title: A First-In-Human, Open-Label, Dose Escalation Trial to Evaluate the Safety and Antitumor Activity of GEN1057 in Subjects With Malignant Solid Tumors

The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer.

Trial details include:

  • The trial duration for an individual participant will be up to approximately 11 months.
  • The treatment duration for an individual participant will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration for an individual participant will be approximately 6 months.

Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.

Read the detailed description

The trial is a first-in-human (FIH) open-label, multicenter, multinational safety trial.

The dose escalation will evaluate different dose levels by assessing safety, tolerability, and early efficacy signals to determine the expansion dose(s) of GEN1057 as monotherapy, as well as characterizing the pharmacokinetic (PK) profile and immunogenicity in participants with malignant solid tumors who have metastatic or advanced disease.

Being tested
GEN1057, Premedication

What participants receive

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

  • GEN1057Drug

    Intravenous (IV) infusion

  • PremedicationDrug

    IV infusion/orally by mouth.

Study groups in NCT06573294
Study groupRoleWhat they receive
GEN1057 MonotherapyExperimentalNot described
Receives: Drug: GEN1057; Drug: Premedication

What is being measured

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

  1. Number of Participants With Treatment-emergent Adverse Events (AEs)

    Measured: From first dose until the end of the safety follow-up period (approximately 5 months)

  2. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.

    Measured: Up to 21 days

Secondary outcomes (10)

  1. Maximum Plasma Concentration (Cmax) of GEN1057

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)

  2. Time to Reach Cmax (Tmax) of GEN1057

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)

  3. Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUC0-last) of GEN1057

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)

  4. Half-life (t1/2) of GEN1057

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)

  5. Clearance (CL) of GEN1057 From Plasma

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)

  6. Number of Participants with Anti-drug Antibodies (ADAs) to GEN1057

    Serum samples will be screened for ADAs binding to GEN1057 and the titer of confirmed positive samples will be reported.

    Measured: Up to approximately 11 months

  7. Objective Response Rate (ORR)

    The ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.

    Measured: Up to approximately 11 months

  8. Duration of Response (DOR)

    DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 11 months

  9. Time to Response (TTR)

    TTR is defined as the time from Cycle 1 Day 1 (C1D1) to the first documentation of objective response (CR or PR) in participants achieving PR or CR based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 11 months

  10. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 11 months

Timeline

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

  1. First posted27 Aug 2024
  2. Study start28 Aug 2024
  3. Primary completion7 Apr 2026
  4. Study completion7 Apr 2026

Why it stopped: Genmab has decided to terminate the GEN1057 program due to marginal anti-tumor activity not supporting further development

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06573294
Sponsor's protocol ID
GCT1057-01
Other IDs
2024-513563-75-00, jRCT2031240508
Status last verified
Nov 2026
First submitted
26 Aug 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
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 GEN1057 and Premedication in people with Advanced Malignant Solid Tumors and Metastatic Malignant Solid Tumors, run by Genmab at 5 sites in 3 countries.

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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 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 5 sites in United States, Spain, 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?

The study was stopped early (reason given: Genmab has decided to terminate the GEN1057 program due to marginal anti-tumor activity not supporting further development). Results are not available in the source record.

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 Treatment-emergent Adverse Events (AEs) (time frame: From first dose until the end of the safety follow-up period (approximately 5 months)). 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 NCT06573294.

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 4 Nov 2026.

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