Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

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

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

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)

Study Official

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

Spots Global Cancer Trial Database for acasunlimab in combination with pembrolizumab (in a separate expansion cohort)