Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: MSP008-22: Total 05 doses of MSP008-22 in the form of oral dose formulation are selected for the trial.
Control Intervention1: NIL: NIL
Sponsors
Godavari Biorefineries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult patients, willing to provide written informed consent and willing to comply to trial requirements, in age range of 18-60 years (both inclusive), with stage IV â?? metastatic or unresectable Solid tumours (Breast cancer including TNBC, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer). 2 Adequate bone marrow function and hepatic & Renal function 3 Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) â?¥ 70 4 Adequate laboratory parameters for Haemoglobin levels, Absolute Neutrophil Count (ANC), Platelets,SGOT,SGPT,Total bilirubin and Serum creatinine. 5 If male, must agree to use contraception and refrain from donating sperm during the treatment period and for â?¥120 days after last dose of trial treatment. 6 If female, is not pregnant or breastfeeding, and agrees to use contraception during the treatment period and for â?¥120 days after last dose of trial treatment.
Exclusion criteria
Exclusion criteria: 1 Patients who have been treated with most recent radiotherapy, immunotherapy, chemotherapy or investigational drugs within â?¤10 days or 5 half-lives (whichever is shorter) from enrolment (screening), and/or who have any unresolved NCI Common Terminology Criteria of Adverse Events (CTCAE) v5.0 > Grade 1 treatment-related side effect, with the exceptions of alopecia 2 Major surgery (excluding placement of vascular access) within 21 days from beginning of the study drug or minor surgical procedures within 7 days. 3 Primary immunodeficiency affecting cellular immunity and active autoimmune disease with the exception of Type I Diabetes Mellitus, hypothyroidism requiring hormone replacement only, an autoimmune dermatologic condition that is managed without systemic therapy, or autoimmune arthritis that is managed without systemic therapy or documented history of autoimmune syndrome or disease. 4 Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication. 5 Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure: Tolerability of MSP008-22 in Human Maximum Tolerated Dose (MTD) [Time Frame: 10 days post dose] Safety of MSP008-22 in Human Incidence of dose-limiting toxicities (DLTs) [Time Frame: 10 days post-dose] Safety of MSP008-22 in Human Incidence of Treatment Emergent adverse events (TEAE); Percent of patients who experience at least 1 Treatment Emergent Adverse Event (TEAE); Percent of patients who discontinue due to TEAE(s). [Time Frame: 30 days post-dose]Timepoint: 30 days post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of MSP008-22 Estimation of plasma and urine pharmacokinetic profile of MSP008-22 [Time Frame: 72 hours post doseTimepoint: 72 hrs | — |
Countries
India
Contacts
Public ContactDr Sangeeta Srivastava
Clinexel Life Sciences Private Limited
Outcome results
None listed