Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: LNP3693: Dose 0.6 mg LNP3693
Frequency once a week(for three weeks in first cycle followed by once in 3 weeks
Route Intravenously
Administration once a week
Duration 6 cycles
Contro
Sponsors
Lupin Limited
Eligibility
Inclusion 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 or lymphoma (NHL) 3. Subjects with solid tumors must have at least one measurable tumor lesion and subjects with NHL must have at least 1 measurable site of disease. 4. Subjects must have an ECOG performance status of 0 or 1. 5. Subjects must have clinical laboratory values within acceptable limits 6. 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. 7. Subjects must have a life expectancy �12 weeks in the opinion of the Investigator. 8. Women of childbearing potential must have a negative serum pregnancy test prior to study entry and agree to use adequate contraception. 9. A male subject must agree to use adequate contraception. 10. Subject must provide written and signed informed consent prior to any Screening procedures and willing to comply with the requirements and restrictions listed in this protocol.
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) of LNP3693Timepoint: at end of Cycle 1 at each dose level MTD will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the safety & tolerability of LNP3693. To determine PK & PD profile of LNP3693Timepoint: Safety & tolerability at Baseline, Cycle3, Cycle5 & end of the study. PK & PD at Cycle 1 & Cycle 2 | — |
Countries
India
Contacts
Public ContactDr. Neelam Kardekar
Lupin Ltd
Outcome results
None listed