This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.
This is an open-label, trial to evaluate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1042 in Japanese participants with malignant solid tumors. The trial consists of 2 parts: a GEN1042 Monotherapy Dose Escalation Part (phase 1a); and a Combination Therapy Part (phase 1b). The purpose of Dose Escalation Part (phase 1a) is to evaluate GEN1042 as monotherapy in participants with non-central nervous system (non-CNS) malignant solid tumors. The Combination Therapy Part (phase 1b) will evaluate GEN1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (SOC) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) and non-small-cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
National Cancer Center East
Kashiwa, Japan
National Cancer Center Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Number of Participants with Dose Limiting Toxicities (DLTs)
Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.
Time frame: During the first cycle (Cycle length = 21 days)
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time frame: From first dose until the end of the treatment (approximately 3 years)
Maximum (Peak) Plasma Concentration (Cmax) of GEN1042
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN1042
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Time to Reach Cmax (Tmax) of GEN1042
Time frame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
Number of Participants with Anti-drug Antibodies (ADA) to GEN1042
Serum samples will be screened for ADAs binding to GEN1042 and the titer of confirmed positive samples will be reported.
Time frame: up to 3 years
Objective Response Rate (ORR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intravenous
Intravenous
ORR is defined as percentage of participants with a best overall response (BOR) (Complete Response (CR) or Partial Response (PR)) confirmed by a subsequent BOR of CR or PR at least 4 weeks later per response evaluation criteria in solid tumors (RECIST) v1.1 based on investigator assessment.
Time frame: Up to 3 years
Duration of Response (DOR)
DOR only applies to participants whose confirmed BOR is CR or PR and is defined as time from the first documentation of objective tumor response (CR or PR) to the date of first disease progression (PD) or death per RECIST criteria v1.1 based on investigator assessment.
Time frame: Up to 3 years
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or Stable Disease (SD) per RECIST criteria v1.1 based on investigator assessment.
Time frame: Up to 3 years
Progression Free Survival (PFS)
PFS is defined as the time from Day 1 in Cycle 1 to the first documented progression or death due to any cause per RECIST criteria v1.1 based on investigator assessment.
Time frame: Up to 3 years