None listed
Conditions
Brief summary
Phase 1 This is trial of the drug BNC105P for treating people with advanced solid tumours. Who is it for? Participation in this study is open to patients who have advanced solid cancers of any type (excluding brain tumours), are 18 years and over and meet the study inclusion and exclusion criteria. Trial details Participants will receive BNC105P intravenously on days 1 and 8 of a 21 day cycle, for a minimum of 2 cycles. Blood tests and imaging will be carried out throughout the treatment cycles to monitor safety, tumour response and suppression of cancer growth. The trial aims to test the safety and determine the maximum tolerated dose of BNC105P. This is an experimental anti-cancer drug which disrupts the blood supply within tumours and is cytotoxic to cancer cells.
Interventions
Two-stage dose escalation study involving intravenous administration of BNC105P on days 1 and 8 of a 21-day cycle. Stage 1 enrolls 1 patient per cohort and commences at 2.3 mg/m2 with 100% increments until significant toxicities are observed (adverse events graded at 2 or higher within the first 21-day cycle). Stage 2 enrolls 3 or more patients per cohort, beginning at the dose level where significant toxicities are observed in Stage 1 and dose increments are either 33%, 50% or 100% depending up
Two-stage dose escalation study involving intravenous administration of BNC105P on days 1 and 8 of a 21-day cycle. Stage 1 enrolls 1 patient per cohort and commences at 2.3 mg/m2 with 100% increments until significant toxicities are observed (adverse events graded at 2 or higher within the first 21-day cycle). Stage 2 enrolls 3 or more patients per cohort, beginning at the dose level where significant toxicities are observed in Stage 1 and dose increments are either 33%, 50% or 100% depending upon the incidence of adverse events (2 or more, 1, or no patients with adverse events, respectively).
Sponsors
Bionomics Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
(i) Confirmed solid malignancy; (ii) Life-expectancy of greater than 12 weeks; (iii) No anticancer chemotherapy for the preceding 4 weeks; (iv) Adequate organ function; (v) Disease amenable to assessment by MRI; (vi) Adequate performance score (Eastern Cooperative Oncology Group score of 0-2)
Exclusion criteria
(i) Patients must not have received other experimental agents in preceding 4 weeks; (ii) Known brain disease; (iii) Patients with various cardiovascular risk factors are excluded; (iv) Pregnancy and immune deficiency; (v) Patients on full dose anticoagulants are excluded.
Outcome results
None listed