RE: RNS11 Aug 2021 12:34
Key Inclusion Criteria:
-Willing and able to give written informed consent
-Male or female patients, =18 years of age
-Histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic pancreatic, CRC, NSCLC,
SCCHN, ovarian, breast, soft tissue sarcoma and bladder cancer, who have either relapsed or progressed on SoC treatment
or are intolerant or nonamenable to SoC treatment
-In Phase 1b part of the study only: At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
as =10mm in the largest diameter (except lymph nodes, which must have a short axis =15 mm) with CT or MRI scan and that
is suitable for accurate repeated measurements.
-Life expectancy of greater than 12 weeks, in the opinion of the investigator
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
-Recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved
to CTCAE grade =1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2)
-Adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving
therapeutic anticoagulation should be on a stable dose):
-Neutrophil count of =1.5× 10^9 cells/L
Haemoglobin =9g/dL (with or without transfusion support)
Platelet count of =75,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
International normalised ratio (INR) and activated partial thromboplastin time (aPTT) =1.5 times the upper limit of normal (ULN)
Adequate liver function:
Total bilirubin =1.5 × ULN (in patients with Gilbert's Syndrome, <3 × ULN is allowed)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × ULN (in patients with liver metastases, <5 × ULN is allowed)
Alkaline phosphatase (ALP) <5 × ULN (patients with documented liver or bone metastases only)
Adequate renal function:
a. Serum creatinine =1.5 × ULN (in patients for whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function, creatinine clearance by ****croft-Gale formula = 50 mL/min may be used)
Women of childbearing potential (WOCBP) and women who have = 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1, Day 1
Contraception requirements:
Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate <1% per year) during the treatment period and for at least 6 months after the last dose of study drug
Male patients with female partners of childbearing potential must agree to use 2 acceptable methods of contraception (Pearl Index failure rate <1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 month
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