Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors
- Conditions
- Advanced Malignant Solid TumorMetastatic Malignant Solid Tumor
- Interventions
- Drug: Premedication
- Registration Number
- NCT06573294
- Lead Sponsor
- Genmab
- 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 will be up to approximately 11 months.
* The treatment duration will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GEN1057 Monotherapy GEN1057 - GEN1057 Monotherapy Premedication -
- Primary Outcome Measures
Name Time Method Number of Participants With Dose Limiting Toxicities (DLTs) Up to 21 days DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.
Number of Participants With Treatment-emergent Adverse Events (AEs) From first dose until the end of the safety follow-up period (approximately 5 months)
- Secondary Outcome Measures
Name Time Method 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) Trough Concentrations (Ctrough) of GEN1057 Predose and postdose at multiple timepoints up to end of treatment (approximately 4 months) Objective Response Rate (ORR) Up to approximately 11 months 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.
Disease Control Rate (DCR) Up to approximately 11 months 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.
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) AUC From Time Zero to Infinity (AUC0-inf) 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) Number of Participants with Anti-drug Antibodies (ADAs) to GEN1057 Up to approximately 11 months Serum samples will be screened for ADAs binding to GEN1057 and the titer of confirmed positive samples will be reported.
Duration of Response (DOR) Up to approximately 11 months 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.
Time to Response (TTR) Up to approximately 11 months 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.
Trial Locations
- Locations (5)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Start Madrid Centro Integral Oncologico Clara Campal CIOCC
🇪🇸Madrid, Spain
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC
🇺🇸San Antonio, Texas, United States
National Cancer Center, Tsukiji 5-1-1
🇯🇵Tokyo, Japan