NL-OMON52764CompletedNot Applicable
A two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib to evaluate safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or metastatic solid tumours. - SYD985 - niraparib combination / solid tumours
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Byondis BV
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •The study population will consist of patients with locally advanced or
- •metastatic solid tumours, complying with the following in- and exclusion
- •criteria: 1. Male or female, age >= 18 years at the time of
- •signing first informed consent; 2. Patient with a histologically-confirmed,
- •locally advanced or metastatic tumour who has progressed on standard therapy or
- •for whom no standard therapy exists, with the following restriction: Part 1:
- •solid tumours of any origin; Part 2: breast cancer, ovarian cancer or
- •endometrial carcinoma/carcinosarcoma; 3. HER2 tumour status at least 1+ as
- •assessed by immunohistochemistry (IHC) as determined by the local laboratory;
- •4. Presence of a tumour lesion accessible for biopsy and patient should be
- •willing to undergo a fresh biopsy for central HER2 testing and genetic testing,
- •unless adequate (biopsy) tumour material is available obtained < 6 months prior
- •to signing the main informed consent; 5. At least one measurable cancer lesion
- •as defined by the Response Evaluation Criteria for Solid Tumours (RECIST
- •version 1.1); 6. Eastern Cooperative Oncology Group (ECOG) performance status <=
- •1; 7. Adequate organ function, evidenced by the following laboratory results:
- •- Absolute neutrophil count >= 1.5 x 109/L; - Platelet count >= 100 x 109/L; -
- •Hemoglobin >= 10.0 g/dL or 6.2 mmol/L; - Total bilirubin <= 1.5 x the upper
- •limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine
- •aminotransferase (ALT) <= 3.0 x ULN (or <= 5.0 x ULN in the presence of liver
- •metastases); - Serum creatinine <= 1.5 x ULN; 8. For women of childbearing
- •potential and male patients with a female partner of childbearing potential,
- •highly effective contraception must be used during the study and up to 6 months
- •after last IMP treatment. This is not required in case the patient or sole
- •partner is surgically sterilized or in case the patient truly abstains from
- •sexual activity.
Exclusion Criteria
- •1. Having been treated with: a. DUBA-containing ADCs at
- •any time; b. Anthracycline treatment within 8 weeks prior to start of study
- •treatment; c. Other anticancer therapy including chemotherapy, immunotherapy,
- •or investigational agents within 4 weeks prior to start of study treatment or 5
- •times the half-life of the therapy, whichever is shorter; d. Radiotherapy
- •within 4 weeks prior to start of study treatment or within 1 week for
- •palliative care (as long as the lungs were not exposed); e. Hormone therapy
- •within 1 week prior to start of study treatment. The patient must have
- •sufficiently recovered from any treatment-related toxicities to NCI CTCAE Grade
- •<= 1 (except for toxicities not considered a safety risk for the patient at the
- •investigator*s discretion); 2. History of infusion-related reactions and/or
- •hypersensitivity to trastuzumab containing treatment, niraparib or excipients
- •of study drugs (e.g. lactose or tartrazine in niraparib) which led to permanent
- •discontinuation of the treatment; 3. History or presence of keratitis; 4. Left
- •ventricular ejection fraction (LVEF) < 50% as assessed by either
- •echocardiography or multigated acquisition (MUGA) scan at screening, or a
- •history of clinically significant decrease in LVEF during previous trastuzumab
- •containing treatment leading to permanent discontinuation of treatment; 5.
- •History (within 6 months prior to start of study treatment) or presence of
- •clinically significant cardiovascular disease such as unstable angina,
- •congestive heart failure, myocardial infarction, uncontrolled hypertension, or
- •cardiac arrhythmia requiring medication; 6. History or presence of idiopathic
- •pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans),
- •drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active
- •pneumonitis on screening chest CT scan; 7. Severe, uncontrolled systemic
- •disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic
- •disease) at screening; 8. Symptomatic brain metastases, brain metastasis
- •requiring steroids to manage symptoms or treatment for brain metastases within
- •8 weeks prior to start of study treatment; 9. Known active Hepatitis B, C or E
- •infection; 10. Major surgery within 4 weeks prior to start of study treatment;
- •11. Pregnancy or lactation; 12. Other condition, which in the opinion of the
- •investigator, would compromise the safety of the patient or the patient's
- •ability to complete the study
Investigators
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