Solid tumours (Study Part 1: solid tumours of any origin
Conditions
Interventions
Investigational medicinal product, mode of administration: SYD985 (Byondis BV,
The Netherlands): [vic-]trastuzumab duocarmazine Drug product vials contain 80
mg sterile lyophilized SYD985 which shou
Sponsors
Byondis BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population will consist of patients with locally advanced or metastatic solid tumours, complying with the following in- and exclusion criteria: Inclusion 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 = 1.5 x 109/L; - Platelet count >= 100 x 109/L; - Hemoglobin >= 10.0 g/dL or 6.2 mmol/L; - Total bilirubin
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: The primary endpoint for Part 1 of the study is: • Incidence of Dose Limiting Toxicity (DLT). The primary endpoint for Part 2 of the study is: • Objective Response Rate (ORR). ORR is defined as the percentage of patients with a best overall tumour response of complete response (CR) or partial response (PR) according to RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints. The endpoints related to safety include: • Incidence and severity of (serious) AEs; • Changes in vital signs and weight; • Changes in ECOG performance status; • Changes in laboratory parameters; • Percentage of patients with confirmed anti-SYD985 antibodies; • Number of patients with dose modifications due to AEs. Efficacy endpoints. Preliminary efficacy will be assessed by: • Objective tumour response rate (ORR); • Clinical benefit rate (CBR); • Number of patients with CR, PR, stable disease (SD) and progressive disease (PD); • Best percent change in target lesion measurements; • Time to response; • Duration of response (DOR); • Progression-free survival (PFS); • Overall survival (OS). CBR is defined as the percentage of patients with CR, PR, SD or non-CR/non-PD (SD or nonCR/non-PD for 6 or more months). Time to response is defined as the time from first day of IMP treatment to first observation of CR or PR. DOR is defined as the duration from first observation of response (CR or PR) to the time of disease progression. PFS is defined as the time from first day of IMP treatment to disease progression or death from any cause. OS is defined as the time from first day of IMP treatment to death from any cause. - Pharmacokinetic endpoints. PK endpoints will include standard parameters such as Cmax, tmax, area under the curve (AUC), Cmin (trough-levels), terminal half-life (t*), volume of distribution, and drug clearance. - Other endpoints. Genetic tumour analysis will be summarized and correlated, if feasible, with response data. | — |
Countries
Netherlands
Outcome results
None listed