CTRI/2024/08/072373
Not Yet Recruiting
Phase 1
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of LNP8701 in Subjects with Metastatic Solid Tumors - NI
upin Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
- Sponsor
- upin Limited
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female subjects \=18 years of age.
- •2\.Subjects must have a histologically or cytologically confirmed diagnosis of metastatic solid tumors.
- •3\.Subjects with solid tumors must have at least one measurable tumor lesion according to response evaluation criteria in solid tumors (RECIST) v1\.1\.
- •Subjects must have an ECOG performance status of 0 or 1\.
- •4\.Subjects must have clinical laboratory values that meet the following criteria:
- •\-Absolute neutrophil count \=1\.5 x 109/L
- •\-Platelets \=100 x 109/L
- •\-Hemoglobin \=9 g/dL
- •\-Serum bilirubin \=1\.5 x upper limit of normal (ULN)
- •\-Aspartate aminotransferase and alanine aminotransferase \=3 x ULN in absence of liver metastases; or \=5 x ULN if the subject has documented liver metastases
Exclusion Criteria
- •1\. Subjects with symptomatic central nervous system (CNS)
- •metastases.
- •2\. History of another primary malignancy except for treated
- •non\-melanoma skin or cervical cancer in situ or ductal cancer in situ.
- •3\. Evidence of clinically significant organ dysfunction.
- •4\. Any major surgery, as determined by the investigator within 30
- •days of screening.
- •5\. Positive screen test for HIV, Hepatitis B, Hepatitis C.
- •6\. History of any relevant allergy/hypersensitivity to the study drugs
- •or its excipient
Outcomes
Primary Outcomes
Not specified
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