Advanced Solid Tumor, Metastatic Solid Tumor
Conditions
Brief summary
Phase l, First in Human, Multi-centre, Open-label, Clinical Trial of MPT0B640 in Subject with Locally Advanced or Metastatic Solid Malignancies Phase I. Advanced or metastatic solid malignancy First in Human. HSP90 inhibitor Multi-center clinical trials. Open label. To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
Detailed description
Classical 3+3 design to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640 . Up to 9 times of administration, Oral suspension, once every 3rd day.
Interventions
DRUGMPT0B640
PO, every 3 days. dose escalation per MTD
Sponsors
J Ints Bio
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all inclusion criteria as listed below: 1. Histologically or cytologically confirmed, locally advanced or metastatic solid malignancies, such as non-small cell lung cancer (NSCLC), breast cancer, hepatocellular carcinoma, colorectal, prostate and pancreatic cancer who is not suitable for surgery or radiotherapy. 2. Subjects who have progressed after receiving all available standard treatment known to confer clinical benefit or for which no effective therapy exists. 3. Radiological documentation of disease progression while on a previous treatment. 4. Discontinued all previous treatment for cancer for at least 14 days and recovered from the effects of therapy. 5. Eastern Cooperative Oncology Group (ECOG) 0 \ 1 6. 19 years and older of age (Adult) 7. At least one measurable lesion by Response Evaluation Criteria in Solid Tumours (RECIST 1.1) 8. Laboratory values: Hematologic parameters must be met without recent transfusions within 7 days of enrolment. 1. Serum creatinine \< 1.5× upper limit of normal (ULN) or if higher than normal range, calculated creatinine clearance (CrCl) must be ≥ 60mL/min/1.73m2 (by Cockroft-Gault formula); actual body weight must be used for CrCl unless body mass index (BMI) \> 30kg/m2 then lean body weight must be used 2. Total bilirubin ≤ 1.5×ULN (except for Gilbert's syndrome which will allow bilirubin ≤2.0 ×ULN). 3. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5×ULN, or ≤ 5×ULN if due to liver involvement by tumour. 4. Haemoglobin ≥ 9.0g/dL. 5. Platelets ≥ 100×109cells/L. 6. Absolute neutrophil count ≥ 1.5×109cells/L. 9. Subjects signed informed contents form 10. Expected lifespan ≥ 3 months 11. Female should be using adequate contraceptive measures, e.g., use at least two of the following types of appropriate and effective birth control from 2 weeks prior to the first dose of the study drug until 90 days after last dose. One of these methods must be a double barrier method (condom with diaphragm plus spermicidal agent \[foam/gel/cream/film/suppository\]). Additional methods are IUD or IUS, vasectomy by sole male partner and use of approved oral, injected, or implanted hormonal methods of contraception. 12. Female should not breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential at screening. 13. Male subjects should be willing to use barrier contraception include using one of the following during the study and for 90 days after last dose of the study drug. (Abstinence, condom plus spermicidal agents \[foam gel/cream/film/suppository\])
Exclusion criteria
Any subject meeting one or more of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD of the dose of MPT0B640 | 28days(+/-2days) |
Outcome results
None listed