None listed
Conditions
Interventions
Drug : Study drug will be provided as a tablet and will be administered orally, once daily, in a 21-day cycle consisting of 14 days treatment ON and 7 days treatment OFF.
Sponsors
Pin Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects =18 years of age at the time of signing the informed consent. However, the legal age of adulthood in each respective country shall apply. 2.Any subject with progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment, and who has exhausted all available therapies or for whom no standard therapy is available. [Backfill cohort only] Subjects with Stage IIIB, IIIC, IV or recurrent solid tumors that have relapsed or are refractory following the last line of treatment and who have exhausted all available therapies or for whom no standard therapy is available. 3.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4.Life expectancy of at least 12 weeks. 5.Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory tests within 7 days prior to the first dosing of PIN-5018. If a subject has received a recent blood transfusion, the laboratory tests must be obtained =2 weeks after any blood transfusion. 6.At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors version 1.1. The measurable lesion must be outside the field of radiation if the subject had prior radiotherapy unless there is clear evidence of progression of the lesion within the radiated zone. 7.Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (two methods strongly recommended) during the study and for 6 months following the last dose of PIN-5018. A highly effective method of birth control is defined in Section 9.11. 8.Female subject of childbearing potential must have a negative serum pregnancy test during the screening period. 9.Female subject must agree not to breastfeed and not to donate ova starting at screening and throughout the study treatment, and for 6 months after the final administration of PIN-5018. 10.A male subject with female partner(s) of childbearing potential must agree to use appropriate dual contraception (defined as the simultaneous use of a condom and a highly effective method of contraception used by the female partner, as outlined in Section 9.11.2) during the treatment period with PIN-5018 and for at least 6 months after the last dose. In addition, they must refrain from donating sperm during this period. 11.A male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a effective dual contraception (defined as the simultaneous use of a condom and a highly effective method of contraception used by the female partner, as outlined in Section 9.11.2) for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of PIN-5018. 12.Willing to provide informed consent as described in Section 9.8.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 13.Subjects must agree to provide a pre-treatment tumor sample in a tissue block or a minimum of 10 unstained serial slides. Pre-treatment fresh biopsy samples are required but an archived tumor sample may be accepted with prior discussion and agreement with the Sponsor. 14.Subjects must agree to provide an on-treatment tumor biopsy (core tissue biopsy or excision) if medically safe in the opinion of the Investigator during the treatment period. 15.Recovered to Gr
Exclusion criteria
Exclusion criteria: 1.Has untreated active brain metastases. Subjects are eligible if brain metastases are adequately treated and subjects are neurologically stable for at least 4 weeks prior to study treatment without the use of corticosteroids or are on a stable dose of steroids (=30 mg/day of hydrocortisone, =2 mg/day of dexamethasone, or =10 mg/day of prednisone [or equivalent]). 2.Has leptomeningeal disease or metastatic spinal cord compression. 3.Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Chronic systemic steroid therapy (in doses exceeding 10 mg of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of PIN-5018 is not permitted. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or a short course of steroids for hypersensitivity reaction to intravenous (IV) contrast is not considered a form of systemic treatment and is permitted. 4.Has active interstitial lung disease or pneumonitis or a history of interstitial lung disease or pneumonitis requiring treatment with steroids or immunosuppressive medications. 5.Has severe peritoneal dissemination. 6.Has pericardial fluid, pleural effusion, or ascites requiring treatment; subjects with these cancer complications who are treated and are stable may be recruited. 7.Discontinued the prior treatment due to intolerable hematologic toxicities. 8.Has received the following treatment: •Prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first dosing of PIN-5018. •Prior chemotherapy including kinase inhibitors within 2 weeks prior to the first dosing of PIN-5018. •Prior radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to the first dosing of PIN-5018. •Major surgery except for placement of vascular access within 4 weeks prior to the first dosing of PIN-5018. 9.Has clinically significant (i.e., active) cardiovascular disease within 6 months prior to initiation of PIN-5018: •History of Long QT syndrome. •Cerebral vascular accident or stroke, myocardial infarction. •Unstable angina, or serious cardiac arrhythmia requiring medication. •Congestive heart failure (New York Heart Association Classification =Class II). 10.Has known positive human immunodeficiency virus (HIV) infection; subjects living with HIV with an indetectable viral load and CD4+ T cell count (CD4) =350 cells/µL may be eligible. 11.Has active hepatitis B or C. An inactive hepatitis B virus carrier whose liver function is clinically normal without medical treatment can be enrolled into the study; a subject treated for hepatitis C with no detectable viral load is permitted. 12.Has infection requiring IV antibiotics within 4 weeks prior to initiation of study drug. 13.Has fever >37°C within 1 week prior to initiation of PIN-5018. 14.Has live vaccine administered against infectious disease within 4 weeks prior to initiation of PIN-5018. 15.Has gastrointestinal tract disease, causing the inability to take oral medication, malabsorption syndrome, or uncontrolled inflammatory gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis). 16.Has psychiatric illness/social situations that would limit compliance with study requirements. 17.H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of PIN-5018 to determine the maximum tolerated dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate preliminary antitumor activity | — |
Countries
Korea, Republic of
Contacts
Public Contactbhumsuk kim
Seoul National University Hospital
Outcome results
None listed