Solid Tumors, Urothelial Carcinoma
Conditions
Brief summary
The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer. The trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial. For each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant). Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \[CT\] scans) to monitor whether the treatment is safe and effective. All participants will receive active drug; no one will be given placebo.
Detailed description
This is a first-in-human (FIH), open-label, multicenter, dose escalation and expansion trial in participants with urothelial and other cancers who have metastatic disease to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of GEN1106.
Interventions
BIOLOGICALGEN1106
Intravenous (IV) infusion.
Sponsors
Genmab
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomization will not be used for the Dose Escalation part. In the Dose Refinement and Expansion parts, randomization may be used.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable. * Have measurable disease according to RECIST v1.1. * Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening. * Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol. * Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC). Key
Exclusion criteria
* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy. * Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration. * Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2. Note: Other protocol-defined Inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs) | 21 days |
| Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 16 months |
| Part 2 Dose Refinement: Number of Participants with AEs and SAEs | Up to approximately 16 months |
| Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 16 months |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1 | Up to approximately 16 months |
| Part 3 Expansion: Number of Participants with AEs and SAEs | Up to approximately 16 months |
| Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106 | Up to approximately 5 months |
| Part 3 Expansion: Number of Participants with ADA to GEN1106 | Up to approximately 5 months |
| Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes | Up to approximately 5 months |
| Part 3 Expansion: Plasma Concentrations of GEN1106-related Analytes | Up to approximately 5 months |
| Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR) per RECIST v1.1 | Up to approximately 16 months |
| Part 3 Expansion: DCR per RECIST v1.1 | Up to approximately 16 months |
| Part 1 Dose Escalation and Part 2 Dose Refinement: Duration of Response (DOR) per RECIST v1.1 | Up to approximately 16 months |
| Part 3 Expansion: DOR per RECIST v1.1 | Up to approximately 16 months |
| Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR) per RECIST v1.1 | Up to approximately 16 months |
| Part 3 Expansion: TTR per RECIST v1.1 | Up to approximately 16 months |
Countries
Japan, Spain, United States
Contacts
CONTACTGenmab Trial Information
STUDY_DIRECTORStudy Official
Genmab
Outcome results
None listed