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

NCT05478486 | Completed Phase 1

• 2 other identifiers: Clinexel-GBL-002CTRI/2022/06/043504
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

Single Ascending Dose; First in Man; FIM; SAD; MSP008; Phase 1

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  to assess Tolerability of MSP008-22 in Human

  10 days post dose

• Incidence of dose-limiting toxicities (DLTs)

  to assess Safety of MSP008-22 in Human

  10 days post-dose

• 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).

  to assess Safety of MSP008-22 in Human

  30 days post-dose

Secondary Outcomes (10)

• Plasma Cmax

  72 hours post dose

• Plasma AUClast

  72 hours post dose

• Plasma AUCinfinity

  72 hours post dose

• plasma tmax

  72 hours post dose

• Plasma t1/2

  72 hours post dose

Study Arms (1)

MSP008-22 treatment arm

EXPERIMENTAL

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

Drug: MSP008-22

Interventions

MSP008-22 DRUG

It is single group assignment interventional model in this clinical trial, consisting of 5 cohorts of 3 patients in each, to be enrolled such that there exists an overall gender balance for the entire trial and to also ensure including minimum five (5) patients of TNBC and minimum five (5) male patients. The trial will be initiated with dosing of a cohort of 03 patient with the Safe starting dose for MSP008-22. Dosing of the patients for the next higher dose cohort will initiate only after: (i) All 03 patients have been recruited in the lower dose Cohort and if a repeat Cohort at this dose level is recommended, another 03 patients have been recruited at same dose level (ii) all dosed patients have completed the allocated study cohort duration, (iii) safety and pharmacokinetic results have been reviewed by the Independent Dose Escalation Committee (DEC) and approved for dose escalation to next cohort.

MSP008-22 treatment arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Godavari Biorefineries Limited: lead

Study Sites (1)

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location

Study Officials

• Deepa Arora, MD

  Clinexel Life Sciences Pvt. Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: It is an open-label clinical trial with a single treatment arm.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At least 3 patients will be enrolled at only one dose level and dosed with one only dose of MSP008-22. Each dosed patient will be evaluated for 72.00 hours post-dose for primary and secondary endpoints (i) If there are no AE or abnormal laboratory results experienced by these three patients, the trial will move to the next dose level (next cohort of 3 different patients), (ii) If in a single Cohort, any one patient experiences any Dose Limiting Toxicity, additional 3 patients will be dosed at the same dose level, (iii) If in a single Cohort, more than 33% of the patients experience Dose Limiting Toxicity, the Cohort will be stopped, and further dose escalation will not happen in the study.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: February 1, 2023
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)