A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)

Phase 1Not Yet RecruitingNCT07827144

AIMEDBIO90 enrolled

Overview

This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time. Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated. Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumours

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs) 2. Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 3. Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour. 4. Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies. 5. Further inclusion criteria apply Exclusion Criteria: 1. Patients who have previously received an agent with the same target as the investigational medicinal product (IMP) 2. Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication 3. Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication 4. Current enrolment in another investigational device or drug trial 5. Further exclusion criteria apply

Locations (6)

Texas Oncology - Irving

Irving, Texas, United States

Austin Health

Heidelberg, Victoria, Australia

Institut Gustave Roussy

Villejuif, France

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period

Time frame: up to 21 days

Secondary Outcomes

Occurrence of adverse events (AEs) during the on-treatment period

Time frame: up to 36 months

Occurrence of AE fulfilling DLT criteria during the on-treatment period

Time frame: up to 36 months

Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107

(duration of a treatment cycle is 21 days; maximum treatment duration is 36 months)