Health Condition 1: C819- Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: GRC 54276: Dosage Form: Capsule
Dose: Starting from 50 mg
Dosage Frequency: Once daily from Day 1 to 21 of each 21-day treatment cycle for maximum 6 cycles
Mode of Administration: Oral
Sponsors
Glenmark Specialty SA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects (=18 years of age) with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not accessible, not tolerated., Have progressed after =1 of systemic therapies for recurrent / metastatic disease and who have not received prior therapy targeting HPK1. 2. At least 1 measurable lesion as defined per RECIST 1.1/Cheson v. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1 measured within 72 hours of treatment. 4. Contraception: Double contraception is required for women with child bearing potential and men. 5. Willing and able to participate in the study and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1.Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results. 2. Subjects with uncontrolled or untreated brain metastasis or leptomeningeal disease. 3. Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions: a. Controlled Type 1 diabetes. b. Hypothyroidism (provided that it is managed with hormone-replacement therapy only). c. Controlled celiac disease. d. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 4. Any active malignancy =2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent. 5. Any condition that required systemic treatment with either corticosteroids ( >10 mg daily of prednisone or equivalent) or other immunosuppressive medication =14 days before the first dose of study drug(s), with the following exceptions: a. Adrenal replacement steroid (dose =10 mg daily of prednisone or equivalent). b. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption. c. Short course (=7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen). 6. Any cancer directed therapy. 7. History of any of the following cardiovascular conditions in the past 12 months: a. Myocardial infarction b. Unstable angina pectoris c. Cardiac angioplasty or stenting d. Coronary/peripheral artery bypass graft e. Class III or IV congestive heart failure per New York Heart Association f. Cerebrovascular accident or transient ischemic attack 8. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases. 9. Pregnant/or planning to get pregnant or breast-feeding women. 10. Any evidence of serious active infections. 11. Subjects who test positive for hepatits B virus, hepatitis C virus or human immunodeficiency virus infection. 12. Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study (based on the Investigator’s judgment). 13. Any known severe allergic reaction to pembrolizumab/atezolizumab or its excipients. . 14. Subjects with history of phototoxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Dose limiting toxicities 2. Incidence of TEAEs and SAEs 3. PK parameters of GRC 54276 (Cmax, Cmax,ss; Cmin,ss; Cavg,ss; AUC0-t and AUC(0-tau); tmax; tmax,ss; Kel; and Percentage of AUC8 observed due to extrapolation from t last to 8.Timepoint: 1. 21 Days 2. From start to end of study 3. from start to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Best overall response rateTimepoint: At all-time point responses during the study;Duration of responseTimepoint: From first documentation of CR or PR to the first documentation of progression;Objective response rateTimepoint: At week 6, 12, 18 and end of treatment;Progression free survivalTimepoint: From the start of treatment to the time of first documented disease progression or death | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals LTD.
Outcome results
None listed