Study to evaluate safety of LNP8701 in patients with different types of Metastatic solid cancers
- Conditions
- Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
- Registration Number
- CTRI/2024/08/072373
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
5.Subjects with history of disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumor type and disease stage, in the opinion of the investigator.
6.Subjects must have a life expectancy =12 weeks in the opinion of the Investigator.
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
7. Use of concomitant medication that might reasonably influence the
results of the study prior to study drug administration and at any time
during the study.
8. Received any therapy such as chemotherapy, radiotherapy, biologic therapy, immunotherapy, other investigational agent within 30 days or a washout of at least 5 half-lives whichever is long with respect to study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine Maximum Tolerated Dose (MTD) of LNP8701Timepoint: From baseline till the end of cycle 1 at each dose level MTD will assessed.
- Secondary Outcome Measures
Name Time Method umber of subjects with adverse events (AEs) & serious AEs (SAEs) & PK parametersTimepoint: At the end of the treatment (approximately 24 weeks).