Health Trials

A Study of GEN1106 in Participants With Solid Tumors

ConditionsSolid TumorsUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenmab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GEN1106

    Biological/Vaccine

    Intravenous (IV) infusion.

Treatment groups

103 Participants
are divided into 3 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose RefinementExperimental treatment 1 intervention
Group C: Part 3: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

Time frame
21 days
2

Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Up to approximately 16 months
3

Part 2 Dose Refinement: Number of Participants with AEs and SAEs

Time frame
Up to approximately 16 months
4

Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
Up to approximately 16 months

Secondary outcomes

1

Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1

Time frame
Up to approximately 16 months
2

Part 3 Expansion: Number of Participants with AEs and SAEs

Time frame
Up to approximately 16 months
3

Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106

Time frame
Up to approximately 5 months
4

Part 3 Expansion: Number of Participants with ADA to GEN1106

Time frame
Up to approximately 5 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

National Cancer Center HospitalRecruiting104-0045, Chuo Ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genmab

Lead sponsor

Source ClinicalTrials.gov
Apply now