Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

GEN1055 will be administered as monotherapy and in combination with a fixed dose of pembrolizumab.

GEN1055 will be administered as monotherapy or in combination with pembrolizumab or in combination with pembrolizumab and standard chemotherapy in separate expansion cohorts, at a dose level selected from the Dose Escalation part.

GEN1055

Standard Chemotherapy

Genmab Trial Information

Study Official

The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer. Participants will receive either GEN1055 alone, GEN1055 with pembrolizumab, or GEN1055 with pembrolizumab and chemotherapy. All participants will receive active drug; no one will receive placebo.

This trial has 2 parts. The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab. The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab (with or without other chemotherapy).

A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens, or until:

* the cancer progresses.
* there are side effects requiring that treatment be stopped.
* the participant decides to not participate further in this trial.
* the doctor believes it is in the participant's best interest to stop treatment.

Participation in the trial will require visits to the site. For the first 12 weeks there will be weekly visits and after that, visits will be every 3 weeks. 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. The trial duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

This is a multi-center trial and will be conducted in two parts: dose escalation (phase 1a/1b) and expansion (phase 2a).

The Dose Escalation part of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) in participants with locally advanced or metastatic solid tumors.

The Expansion part will evaluate safety, tolerability, mechanism of action (MoA), immunogenicity, pharmacokinetic (PK), and initial antitumor activity of the selected doses and schedules in selected tumor indications.

Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy

First-In-Human, Open-Label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects With Malignant Solid Tumors

Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

ORR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by investigator.

Serum samples will be screened for ADAs binding to GEN1055 and the titer of confirmed positive samples will be reported.

ORR is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1 as assessed by investigator.

DOR based on investigator assessment 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 according to RECIST v1.1 as assessed by investigator.

TTR based on investigator assessment is defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of objective response (CR or PR) in participants achieving PR or CR according to RECIST v1.1 as assessed by investigator.

The DCR is defined as the proportion of participants with BOR of CR, PR, or Stable Disease (SD) according to RECIST v1.1 as assessed by investigator.

OS is defined as the time from C1D1 to the date of death due to any cause.

PFS is defined as the time from C1D1 to first documented PD or death due to any cause, whichever occurs earlier according to RECIST v1.1 as assessed by investigator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy	NCT06391775	Malignant Solid...	GEN1055 Pembrolizumab Standard Chemot...	18 Years -	Genmab
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy	NCT06391775	Malignant Solid...	GEN1055 Pembrolizumab Standard Chemot...	18 Years -	Genmab

Spots Global Cancer Trial Database for gen1055

Every month we try and update this database with for gen1055 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gen1055

Every month we try and update this database with for gen1055 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gen1055 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.