Status:
RECRUITING
Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors
Lead Sponsor:
Genmab
Conditions:
Advanced Malignant Solid Tumors
Metastatic Malignant Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 par...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06573294
Start Date
August 28 2024
End Date
February 1 2027
Last Update
January 6 2026
Active Locations (5)
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1
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
2
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
3
National Cancer Center, Tsukiji 5-1-1
Tokyo, Japan
4
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035