RECRUITING

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

Conditions

Advanced Malignant Solid Tumors Metastatic Malignant Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-28

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06573294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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. * 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* 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.

Contacts and Locations

Study Contact

Genmab Trial Information

CONTACT

+4570202728

clinicaltrials@genmab.com

Principal Investigator

Study Official

STUDY_DIRECTOR

Genmab

Study Locations (Sites)

SCRI Oncology Partners

Nashville, Tennessee, 37203

United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Genmab

Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2024-08-28

Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

Advanced Malignant Solid Tumors
Metastatic Malignant Solid Tumors