Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pembrolizumab

Fluorouracil

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

GEN1042

5-Fluorouracil

Genmab Trial Information

Study Official

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.

The Combination Therapy Part (phase 1b) will evaluate GEN1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (SOC) chemotherapy.

A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GEN1042 Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Japanese Subjects With Malignant Solid Tumors

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

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.

Serum samples will be screened for ADAs binding to GEN1042 and the titer of confirmed positive samples will be reported.

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.

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.

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.

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.

BioNTech SE

Genmab

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Adenocarcinoma

Melanoma

Squamous Cell Carcinoma of Head and Neck

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

Micronutrients

Hematinics

Vitamins

Paclitaxel

Gemcitabine

Pemetrexed

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).

GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer \[NSCLC\], head and neck squamous cell carcinoma \[HNSCC\], and pancreatic cancer.

5-FU

Nab paclitaxel

Genmab A/S Trial Information

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.

This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.

GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator

Defined as proportion of participants who have a confirmed partial or complete response (PR or CR). Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0

Defined as time from the first documentation of objective response (CR or PR) to the date of first PD or death.

Determined by Investigator Using RECIST Version 1.1

Defined as the time from start of study treatment to first documented progression per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.

Defined as the time from start of study treatment to date of death due to any cause.

Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Maximum Concentration (Cmax) of GEN1042

Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042

Dose Escalation: Half-life (t1/2) of GEN1042

Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042

Dose Expansion: Maximum Concentration (Cmax) of GEN1042

Dose Escalation: Incidence of ADA response to GEN1042responses to GEN1042

Dose Expansion: Incidence of ADA response to GEN1042

Radiotherapy

The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization).

Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2.

Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1.

Participants in both parts are treated with one of the following combinations:

* Radiotherapy + GEN1042
* Radiotherapy + GEN1042 + Pembrolizumab

While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.

Part 1 is sequential, Part 2 is parallel (randomized)

A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors

Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

ORR is defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) v1.1 as assessed by investigator.

DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator.

The disease control rate (DCR) is defined as the percentage of participants with BOR of CR, PR, and stable disease (SD) according to RECIST v1.1.

PFS is defined as the time from the date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator.

OS is defined as the time from date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors	NCT06057038	Malignant Solid...	GEN1042 Pembrolizumab Cisplatin Carboplatin 5-Fluorouracil	18 Years -	Genmab
GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors	NCT04083599	Malignant Solid... Non Small Cell ... Colorectal Canc... Melanoma Head and Neck S... Pancreatic Duct...	GEN1042 Pembrolizumab Cisplatin Carboplatin 5-FU Gemcitabine Nab paclitaxel Pemetrexed Paclitaxel	18 Years -	Genmab
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors	NCT06057038	Malignant Solid...	GEN1042 Pembrolizumab Cisplatin Carboplatin 5-Fluorouracil	18 Years -	Genmab
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors	NCT06057038	Malignant Solid...	GEN1042 Pembrolizumab Cisplatin Carboplatin 5-Fluorouracil	18 Years -	Genmab
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors	NCT05491317	Non-CNS Tumor	GEN1042 Pembrolizumab Radiotherapy	18 Years -	Genmab
GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors	NCT04083599	Malignant Solid... Non Small Cell ... Colorectal Canc... Melanoma Head and Neck S... Pancreatic Duct...	GEN1042 Pembrolizumab Cisplatin Carboplatin 5-FU Gemcitabine Nab paclitaxel Pemetrexed Paclitaxel	18 Years -	Genmab

Spots Global Cancer Trial Database for gen1042

Every month we try and update this database with for gen1042 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 gen1042

Every month we try and update this database with for gen1042 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 gen1042 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.