Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immune Checkpoint Inhibitors

Pembrolizumab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles

Treatment with acasunlimab + pembrolizumab once every 21 days

Treatment with acasunlimab+ pembrolizumab once every 42 days

Acasunlimab will be administered intravenously (IV)

Acasunlimab

Genmab A/S Trial Information

The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care

This trial is a randomized, open-label trial evaluating the safety and efficacy of acasunlimab (GEN1046) as monotherapy and in combination therapy with pembrolizumab.

The trial consists of two parts; a safety phase and an extension phase. The extension phase will be initiated once the safety phase is completed.

Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor

ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per RECIST v1.1

DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first.

TTR will be measured as the time from first treatment to onset of initial response (CR or PR) as per RECIST v.1.1

PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first

Defined as time to death from of any cause

Incidence of treatment-emergent AEs as assessed by CTCAE v5.0. Laboratory parameters graded by CTCAE v5.0

BioNTech SE

Merck Sharp & Dohme LLC

Genmab

Acasunlimab will be administered intravenously (IV) once every 21 days.

Pembrolizumab will be administered IV once every 21 days.

Study Official

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.

The starting dose is 15 mg administered as a flat dose. Dose escalation steps are based on safety data.

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

Open-label, Dose-escalation Trial to Evaluate the Safety and Pharmacokinetics of GEN1046 in Japanese Subjects With Advanced Solid Malignancies

Determine the DLT profile of acasunlimab administered as monotherapy or in combination with pembrolizumab. The DLTs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Squamous Cell

Breast Neoplasms

Triple Negative Breast Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Transitional Cell

Squamous Cell Carcinoma of Head and Neck

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Skin Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Docetaxel

Tubulin Modulators

Antimitotic Agents

Acasunlimab will be administered as monotherapy

Acasunlimab will be administered as monotherapy (or in combination with docetaxel or in combination with pembrolizumab or in combination with pembrolizumab and standard chemotherapy in separate expansion cohorts)

Acasunlimab will be administered intravenously once every 21 days (in selected expansion cohorts acasunlimab will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles)

Acasunlimab and docetaxel will be administered intravenously once every 21 days

Acasunlimab in combination with docetaxel (in a single expansion cohort)

Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively

Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)

Acasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days

Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)

The purpose of the trial is to evaluate the safety of acasunlimab (also known as GEN1046) as monotherapy and in combination therapies in patients with malignant solid tumors

The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a)). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

Incidence of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Laboratory parameters graded by CTCAE v5.0

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by Independent Review Committee (IRC)

Total body clearance of drug from the plasma

The area under the curve (AUC) from time zero to day 21

The AUC from time zero to last quantifiable measurement

The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration

The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration

The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve

Rate of subjects with objective response assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Rate of subjects with disease control assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Duration of Response assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

Laboratory parameters graded by CTCAE v5.0 (Listing of all laboratory data with values flagged and shift tables)

Duration of Response assessed by independent review committee using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Progression free survival assessed by independent review committee and assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Pembrolizumab will be administered in combination with acasunlimab as second-line (2L) or third-line (3L) therapy for dMMR/MSI-H in checkpoint inhibitor (CPI) naïve participants.

Pembrolizumab will be administered in combination with acasunlimab as 2L or 3L therapy for mismatch repair deficient/ microsatellite instability-high (dMMR/MSI-H) participants who had prior exposure to programmed cell death protein/ programmed death ligand 1 (PD-1/PD-L1) inhibitors.

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are:

* How well acasunlimab in combination with pembrolizumab works against endometrial cancer
* What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab

Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

This is an open-label multicenter study in participants with advanced (unresectable and/or metastatic) endometrial cancer to evaluate the safety and clinical activity of acasunlimab (GEN1046) in combination with immunotherapy.

The trial consists of two cohorts:

* Cohort A (cohort closed)
* Cohort B

The study will enroll approximately 80 participants in Cohort A and B (approximately 40 participants in each cohort).

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

ORR is defined as the percentage of participants with a confirmed response of partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

DOR is defined for responders as the time from initial onset of response to first progression event, defined as radiographic progression or death as per RECIST v1.1.

TTR is defined as the time from first infusion of trial treatment to onset of response as per RECIST v1.1.

DCR is defined as the proportion of participants with a confirmed response of PR or CR or stable disease (SD) according to RECIST v1.1.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product as per CTCAE V5.0. TEAE is defined as an AE occurring or worsening between the first dose of study drug and 30 days after the last dose received.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer	NCT05117242	Non Small Cell ...	Acasunlimab Pembrolizumab	18 Years -	Genmab
GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies	NCT04937153	Solid Tumor	Acasunlimab Pembrolizumab	20 Years -	Genmab
GEN1046 Safety Trial in Patients With Malignant Solid Tumors	NCT03917381	Solid Tumors Non-small Cell ... Urothelial Carc... Endometrial Car... Triple Negative... Squamous Cell C... Cervical Cancer	Acasunlimab Acasunlimab in ... Acasunlimab in ... Acasunlimab in ...	18 Years -	Genmab
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer	NCT06046274	Advanced Endome...	Pembrolizumab Acasunlimab	18 Years -	Genmab
Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer	NCT05117242	Non Small Cell ...	Acasunlimab Pembrolizumab	18 Years -	Genmab

Spots Global Cancer Trial Database for acasunlimab

Every month we try and update this database with for acasunlimab 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 acasunlimab

Every month we try and update this database with for acasunlimab 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 acasunlimab 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.