Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

Inclusion Criteria25

• Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
• Has an ECOG performance status score of 0 or 1.
• Has a life expectancy of \> 12 weeks in the opinion of the investigator.
• Measurable or evaluable disease by CT/MRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.
• Histologically or cytologically confirmed locally advanced/metastatic solid cancers.
• Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:
• Laboratory Value
• Hematology
• Platelet count \> 100 x 109/L
• Hb \> 9.0 g/dL
• ANC \> 1.5 x 109/L
• Renal Function
• Creatinine \< 1.5 x ULN
• Hepatic Function
• AST and ALT \< 3 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
• Total bilirubin ≤ 1.5 x ULN
• Serum albumin ≥ 2.5 g/dL
• INR/PT and APTT ≤ 1.5 x ULN
• Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.
• Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.
• Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.
• Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).
• Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).
• Defined diseases or disease states of interest, suitable for dose expansion.
• Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.