Health Condition 1: C00-D49- Neoplasms Health Condition 2: D49-D49- Neoplasms of unspecified behavior
Conditions
Interventions
Intervention1: LNP7457: 0.5 mg and 1 mg Tablets for oral administration. LNP7457 will be administered orally in 21-day cycle consisting of daily dosing for first 16 days (on-period) followed by no tre
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 locally advanced or metastatic pancreatic, head and neck, breast and colon cancer. 3. Subjects with solid tumors must have at least one measurable tumor lesion according to RECISTV1.1 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 with at least prior 2 line of anticancer therapy who in the opinion of investigator can benefit by addition of LNP7457 to their anti-cancer SoC treatment. 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 efficacy of LNP7457 in subjects with selected cancersTimepoint: To characterize the safety and tolerability of LNP7457 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine efficacy of LNP7457 in subjects with selected cancers. To determine profile PK/PD of LNP7457.Timepoint: Solid tumor cohort Objective Response Rate (ORR) & Clinical Benefit Rate (CBR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. | — |
Countries
India
Contacts
Public ContactDr. Neelam Kardekar
Lupin Ltd
Outcome results
None listed