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This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CH5132799 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CH5132799 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose limiting toxicities | Upon completion of the study | |
| Preliminary anti-tumour activity | Upon completion of the study |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics of CH5132799 | Upon completion of the study | |
| To characterise the pharmacodynamic effect of CH5132799 in surrogate tissues | Upon completion of the study |
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Inclusion Criteria:
Provision of signed written informed consent.
Histologically or cytologically confirmed diagnosis of advanced solid tumor.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Life expectancy of ≥ 12 weeks.
Disease measurability:
Patients must have a measurable - as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 - and/or evaluable disease.
Paraffin-embedded archival tumor tissue available. Fresh biopsies will be required if no paraffin embedded tumor tissues available.
Adequate bone marrow function.
Adequate cardiac function: Patient should have Left Ventricular Ejection Fraction (LVEF) of ≥ 50% as determined by echocardiography (ECHO) or Multi Gated Acquisition (MUGA) scans.
Adequate liver function.
Adequate renal function.
Adequate adrenal function assessed by baseline cortisol of > 200 nmol/L
Ability to comply with protocol requirements.
Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients who have been sterilized must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment.
Female patients of child-bearing potential must have a negative serum pregnancy test within the seven days prior to the first study drug administration.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Sites | London | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| C559137 | CH 5132799 |
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