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

NCT06573294 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: GCT1057-012024-513563-75-00jRCT2031240508
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 5

Brief 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.
• 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.

Conditions

Advanced Malignant Solid Tumors; Metastatic Malignant Solid Tumors

Outcome Measures

Primary Outcomes (2)

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

  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.

  Up to 21 days

Secondary Outcomes (10)

• Maximum Plasma Concentration (Cmax) of GEN1057

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

• Time to Reach Cmax (Tmax) of GEN1057

  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

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

• Half-life (t1/2) of GEN1057

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

• Clearance (CL) of GEN1057 From Plasma

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

Study Arms (1)

GEN1057 Monotherapy

EXPERIMENTAL

Drug: GEN1057; Drug: Premedication

Interventions

Premedication DRUG

IV infusion/orally by mouth.

GEN1057 Monotherapy

GEN1057 DRUG

Intravenous (IV) infusion

GEN1057 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (5)

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

RECRUITING

National Cancer Center, Tsukiji 5-1-1

Tokyo, Japan

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Start Madrid Centro Integral Oncologico Clara Campal CIOCC

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Interventions

Premedication

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 21, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); ES (2); US (2)