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
Conditions the study is for: Advanced Malignant Solid Tumors, Metastatic Malignant Solid Tumors
What is being tested?: GEN1057 and Premedication
Type of treatment: Pill or oral medicine, Injection or infusion
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

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.

Country

City, postcode or hospital

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.

Conditions: Advanced Malignant Solid Tumors, Metastatic Malignant Solid Tumors
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 group	Role	What they receive
GEN1057 Monotherapy	Experimental	Not described Receives: Drug: GEN1057; Drug: Premedication

What is being measured

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

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)
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)

Maximum Plasma Concentration (Cmax) of GEN1057
Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
Time to Reach Cmax (Tmax) of GEN1057
Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
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)
Half-life (t1/2) of GEN1057
Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
Clearance (CL) of GEN1057 From Plasma
Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months)
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
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
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
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
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.

28 Aug 20247 Apr 2026

First posted27 Aug 2024
Study start28 Aug 2024
Primary completion7 Apr 2026
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

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
More trials run by GenmabThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Sep 2026
First submitted: 26 Aug 2024
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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