TAILOR: This trial is evaluating individually tailored treatment plans in people with advanced cancers who are accessing targeted therapy cancer drugs through compassionate accessSafety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Inclusion

1. Patient or their parent(s)/legal guardian(s) has provided written informed consent using the main study PICF

2. Continues to meet all the inclusion criteria as per the TRIAGE Framework protocol as follows:

   1. Male or female patient, aged 2 years or older
   2. Patient has pathologically confirmed locally advanced, incurable or metastatic cancer of any histological type
   3. Have an available TRIAGE sub-study with a matched therapy
   4. Documented progression following standard therapy, or for whom, in the opinion of the Investigator, no appropriate standard therapy exists
   5. Life expectancy of > 3 months
   6. Adequate performance status:

   i. For patients aged 18 years or over, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (appendix 1) ii. For patients aged 17 years, Karnofsky score ≥ 50 (appendix 2) iii. For patients aged 16 years or under, Lansky score ≥ 50 (appendix 3)

3. Treatment regimen and schedule of assessments that has been approved by the TAILOR Study Committee
4. Approved treatment is obtainable
5. Patient has measurable disease or evaluable disease as defined by RECIST 1.1 (or RANO criteria for primary CNS cancers or the Cheson (IWG) revised response criteria for lymphomas)

6. Patient must have adequate bone marrow, hepatic and renal function within 7 days prior to registration:

   • ANC ≥ 1.5 x 109/L
   • Platelet count ≥ 100 x 109/L (platelet count ≥ 50 x 109/L for haematological malignancy indications)
   • ALT ≤ 2.5x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5x ULN
   • AST ≤ 2.5x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5x ULN
   • Total bilirubin ≤ 1.5x ULN except patients with Gilbert's Syndrome, who are eligible in consultation with their physician
   • Serum creatinine ≤ 1.5x ULN
7. Patient is willing and able to comply with the protocol for the duration of the study including undergoing, treatment, and scheduled visits and examination including follow up
8. Female patients of childbearing potential must have a negative serum pregnancy test at screening for the main study and agree to use highly effective methods of birth control while receiving approved treatment through to the time frame specified in the approved ITAP after the last dose. Patients of childbearing potential are those who have not been surgically sterilised or have not been free from menses for > 1 year.
9. Sexually active males must agree to use a condom during intercourse while taking the approved treatment through to the time frame specified in the approved ITAP after the last dose and should not father a child in this period.