Early Access Study of Zongertinib for the Treatment of Cancer in Patients Eligible for Anticancer Therapy

Trial ID: 2025-524769-26-00
Sponsor: HUS-yhtymae

Trial statistics

science

test molecule

location_city

research sites

public

country

medical_information

disease

person_search

investigators

Diseases & Conditions

Neoplasm malignant

Objectives

The primary objective is to evaluate the anti‑tumor activity and toxicity of anti‑cancer drugs that are approved, under regulatory review, or have established safety profiles, when used for the treatment of cancer; this assessment provides essential efficacy and safety information to inform early‑access therapeutic decisions.

Secondary objectives are:

Optional biomarker analyses, including next‑generation sequencing, on fixed or fresh tumor samples and liquid biopsies.
Characterization of pathway activations and resistance mechanisms that may drive progression during therapy.

Participants

The trial enrolled adult patients (≥ 18 years) of both sexes with a histologically confirmed diagnosis of cancer; the sponsor did not provide the total number of participants. Eligibility required an ECOG performance status of 0–2 and acceptable organ function as defined by specific laboratory thresholds, without recent transfusion or growth‑factor dependence. Candidates needed objectively measurable disease per standard response criteria and, when applicable, molecular profiling demonstrating an actionable tumor variant. Participants had to be capable of providing informed consent, able to swallow oral medication if required, and agree to appropriate contraception throughout the study and for four months after treatment. Selection was based on these clinical and laboratory criteria rather than lifestyle factors such as diet or physical activity.

Plans and Procedures

The study, titled FINACCESS, is a phase 4 early‑access trial evaluating the anti‑tumor activity and toxicity of the oral investigational product BI 1810631 (containing the active substance zongertinib) in adult patients with histologically confirmed cancer. After providing informed consent, participants undergo a screening visit to confirm eligibility criteria, including ECOG performance status 0‑2, adequate organ function, and measurable disease per RECIST v1.1 or other disease‑specific response criteria. Eligible subjects then begin treatment at a dose of 120 mg once daily and attend scheduled follow‑up visits for safety monitoring, laboratory assessments, and disease evaluation; the frequency of these visits follows the protocol‑specified timeline. The trial concludes with an end‑of‑study visit during which final efficacy and safety data are collected. The primary endpoint is the assessment of anti‑tumor activity and toxicity, while secondary objectives include optional biomarker analyses and investigation of resistance mechanisms. Recruitment commenced on 2 March 2026 and the overall study is planned to close on 28 February 2039, with each participant remaining in the study from screening through the final end‑of‑study assessment.

Treatment

The investigational product designated BI 1810631 contains the active substance zongertinib and is supplied as a film‑coated tablet for oral administration. Each tablet delivers a dose of 120 mg. The medication is administered according to the protocol‑specified schedule, with dosing recorded in the study case report form and adherence monitored by pill count and patient diary entries.

No additional investigational agents are employed in this study. Participants receive standard supportive care as required by clinical practice, but no placebo or active comparator is described in the protocol.

Efficacy

Efficacy will be evaluated by assessing anti‑tumor activity of the investigational drug in patients with cancer, as defined in the primary study objective. Secondary efficacy‑related assessments include optional biomarker analyses performed on fixed and fresh tumor specimens or liquid biopsies to explore pathway activation and resistance mechanisms.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

Adult (age ≥18 years) patient with a histologically confirmed cancer.
ECOG performance status 0-2
Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manuals will take precedence: a. Absolute neutrophil count ≥ 1.5 x 109/l b. Hemoglobin ≥ 90 g/l c. Platelets ≥ 75 x 109/l For hematological patients: 3.c. is not applicable for hematological cancers as abnormal blood counts are often caused by advanced disease, and they normalize with successful therapy. d. Total bilirubin ≤ 1.5 x ULN e. AST and ALT < 3 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases) f. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2 g. Criteria must be met without growth factor dependency and without packed red blood cell (pRBC) transfusion within last 14 days before screening period.
Patients must have objectively evaluable or measurable disease (by physical or radiographic or laboratory examination, according to the RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRECIST or PCWG3. Criteria used outside previously listed will be defined separetaly in cohort specific amendment.
When drug selection is based on actionable target, molecular profiling of tumor must be analysed in accrediated diagnostic laboratory and results must reveal a potentially actionable variant as defined in Section 5.
Ability to understand and the willingness to sign a written or electronic informed consent document and to comply to the protocol.
For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
Because of the risks of drug treatment to a developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following the completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug or completely abstain from sexual intercourse

cancel

Exclusion Criteria

Ongoing toxicity > grade 2, other than alopecia or > grade 1 neuropathy.
Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash-out period prior to starting study treatment is at least two weeks. An exception is made for: Patients suffering from CRPC are allowed to continue androgen deprivation therapy. Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study. Palliative radiotherapy for symptom management during the study treatment may be given after the consultation with study sponsor.
Patient is pregnant or nursing.
Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient is clinically stable and off steroids for at least 4 weeks prior to study initiation.
Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
Patients with known left ventricular ejection fraction (LVEF) < 45% are not eligible.
Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible.
Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, drug abuse or severe psychiatric illness/social situations.