Assessment of Safety, Tolerability and PK Profile of MSP008-22 in Patients With Advanced Solid Tumours
- Registration Number
- NCT05478486
- Lead Sponsor
- Godavari Biorefineries Limited
- Brief Summary
This is the 'first-in-human' clinical trial of the Investigational Medicinal Product (IMP), Tablet formulation for Oral dosing of MSP008-22, a molecule (new chemical entity) with anticancer properties.
- Detailed Description
This Single Ascending Dose (SAD) clinical trial is designed to evaluate the safety and tolerability of single oral ascending doses of the IMP in patients with Stage IV of advanced solid tumours including but not limited to Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).
The trial will also assess the pharmacokinetic (PK) profile of MSP008-22 in humans.
The safety, tolerability and PK data from this trial will determine the safety of MSP008-22 for dosing in humans in further clinical trials.
As MSP008-22 has shown efficacy in in vitro studies against various cancer cell lines and in prostate and breast cancer cell lines in xenograft studies, the first in human trial of MSP008-22 is planned in patients of 'Stage-IV of Advanced Solid Tumours (Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer and other advanced solid tumors).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
- 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 - metastatic or unresectable Solid tumours (Breast cancer including TNBC, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).
- Adequate bone marrow function and hepatic & Renal function
- Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) ≥ 70
- Adequate laboratory parameters for Haemoglobin levels, Absolute Neutrophil Count (ANC), Platelets, AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), Total bilirubin ≤ 1.5 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN), and Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min
- If male, must agree to use contraception and refrain from donating sperm during the treatment period and for ≥120 days after last dose of trial treatment.
- If female, is not pregnant or breastfeeding, and agrees to use contraception during the treatment period and for ≥120 days after last dose of trial treatment.
- Patients who have been treated with most recent radiotherapy, immunotherapy, chemotherapy or investigational drugs within ≤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
- Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days.
- 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.
- Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication.
- Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MSP008-22 treatment arm MSP008-22 Oral Escalating doses of MSP008-22- total five doses, each in form of a single dose oral formulation/tablet. Each trial participant will receive only one single oral dose of 05 identified dose levels of MSP008-22. Intra-patient dose escalation will not be carried out
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) 10 days post dose to assess Tolerability of MSP008-22 in Human
Incidence of dose-limiting toxicities (DLTs) 10 days post-dose to assess Safety of MSP008-22 in Human
Incidence of Treatment Emergent adverse events (TEAE); % of patients who experience at least 1 Treatment Emergent Adverse Event (TEAE); % of patients who discontinue due to TEAE(s). 30 days post-dose to assess Safety of MSP008-22 in Human
- Secondary Outcome Measures
Name Time Method Vz/F 72 hours post dose (apparent volume of distribution of MSP008-22 during the terminal phase following administration, estimated using formula)
Plasma Cmax 72 hours post dose (maximum measured concentration of MSP008-22 in plasma)
Plasma AUClast 72 hours post dose (area under the plasma concentration time curve of MSP008-22 from hour 0 to last sample with measurable plasma concentrations)
Plasma AUCinfinity 72 hours post dose (area under the concentration-time curve of MSP008-22 in plasma over the time interval from 0 extrapolated to infinity)
plasma tmax 72 hours post dose (time from dosing to maximum measured concentration of MSP008-22 in plasma)
Plasma t1/2 72 hours post dose (terminal half-life of MSP008-22 in plasma)
CLr 72 hours post dose (and the apparent renal clearance of MSP008-22)
CL/F 72 hours post dose (total clearance of MSP008-22 in plasma after administration estimated using formula)
Ae 72 hours post dose (the total amount of MSP008-22 excreted in urine)
Ae %dose 72 hours post dose (the percent of MSP008-22 recovered in urine)
Trial Locations
- Locations (1)
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre
🇮🇳Navi Mumbai, Maharashtra, India