Assessment of Safety, Tolerability and PK Profile of MSP008-22 in Patients With Advanced Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Godavari Biorefineries Limited

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 - 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) ≥ 70

4. 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

5. 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.

6. 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.

Exclusion Criteria:

1. 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

2. Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤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.