NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy… (NCT04851834) | Clinical Trial Compass
TerminatedPhase 1/2
NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma
Stopped: Study was terminated by IP Holder (collaborator), PinotBio Inc.
Australia12 participantsStarted 2021-08-25
Plain-language summary
This is a Phase 1/2, open-label, dose-exploration, combination/expansion study, which will start by evaluating the safety and tolerability of NTX-301, an oral DNMT1 inhibitor, as a monotherapy in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease. It will then explore the safety and tolerability of NTX-301 in combination with platinum-based therapy in patients with ovarian and bladder cancer. Optionally, the safety and tolerability of NTX-301 in combination with Temozolomide (TMZ) in patients with Isocitrate Dehydrogenase 1 (IDH1) mutated high-grade glioma will also be assessed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to understand and be willing to sign an informed consent form.
✓. Male or female, ≥ 18 years old at the time of screening.
✓. Diagnosis of histologically or cytologically confirmed:
✓. Locally advanced or metastatic cancer (all solid tumours). Subjects must be considered refractory or intolerant to SOC therapies or have refused standard therapy. If the last treatment a subject received was an inhibitor of DNA synthesis or a hypomethylating agent, at least 5 half-lives must have passed prior to commencing treatment. (Phase 1a, Dose Escalation Monotherapy), OR
✓. Locally advanced or metastatic cancer (ovarian or bladder cancer and other solid tumours where in the opinion of the investigator, retreatment with cisplatin or carboplatin may be beneficial to the subject). Subjects must be considered refractory or intolerant to SOC therapies or have refused standard therapy, in such a case, reason for the refusal to be captured in Case Report Form (CRF). If subject is having a drug holiday to recover from cisplatin toxicity, entry to the trial is allowed if the PI feels the subject will receive further benefit from cisplatin, the toxicity has recovered to ≤ CTCAE Grade 1 and all other eligibility criteria are met. Last treatment prior to trial entry with a platinum is not required. If the last treatment a subject received was an inhibitor of DNA synthesis or a hypomethylating agent, at least 5 half-lives must have passed prior to commencing study treatment). (Phase 1b, Dose \& Disease Expansion Combination Arms, Arms 1 \& 2), OR
What they're measuring
1
Safety & Tolerability: Incidence, type, and severity of Adverse Events (AE)
. High-grade glioma, such as glioblastoma multiforme (GBM) that are:
✓. Eastern Cooperative Oncology Group performance status of 0 to 1
✓. Able to take oral medications and willing to record daily adherence to the study drug.
Exclusion criteria
✕. Investigational agents, including hypomethylating agents, in the past 5 half-lives
✕. Patients with symptomatic brain metastases.
✕. Evidence of abnormal cardiac function as defined by any of the following:
✕. Myocardial infarction within 6 months of Cycle 1, Day 1
✕. Symptomatic congestive heart failure (New York Heart Association \> class II)
✕. Unstable angina
✕. Unstable cardiac arrhythmia. Stable cardiac arrhythmia that is Medically managed is allowable. Borderline subjects are allowable on a case-by-case basis as per the discretion of the Principal Investigator and approval by the Medical Monitor and Sponsor.