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

Advanced Solid Tumor Clinical Trial

Official title:

A Single Ascending Dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetic Profile of MSP008-22 in Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05478486
• Other study ID #: Clinexel-GBL-002
• Secondary ID: CTRI/2022/06/043
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: July 2022
• Source: Godavari Biorefineries Limited
• Contact: Sangeeta Srivastava, PhD
• Phone: 02261702100
• Email: sangeeta[@]somaiya.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: January 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• MSP008-22
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.

Locations

Country	Name	City	State
India	Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre	Navi Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Godavari Biorefineries Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	to assess Tolerability of MSP008-22 in Human	10 days post dose
Primary	Incidence of dose-limiting toxicities (DLTs)	to assess Safety of MSP008-22 in Human	10 days post-dose
Primary	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	Plasma Cmax	(maximum measured concentration of MSP008-22 in plasma)	72 hours post dose
Secondary	Plasma AUClast	(area under the plasma concentration time curve of MSP008-22 from hour 0 to last sample with measurable plasma concentrations)	72 hours post dose
Secondary	Plasma AUCinfinity	(area under the concentration-time curve of MSP008-22 in plasma over the time interval from 0 extrapolated to infinity)	72 hours post dose
Secondary	plasma tmax	(time from dosing to maximum measured concentration of MSP008-22 in plasma)	72 hours post dose
Secondary	Plasma t1/2	(terminal half-life of MSP008-22 in plasma)	72 hours post dose
Secondary	CL/F	(total clearance of MSP008-22 in plasma after administration estimated using formula)	72 hours post dose
Secondary	Vz/F	(apparent volume of distribution of MSP008-22 during the terminal phase following administration, estimated using formula)	72 hours post dose
Secondary	Ae	(the total amount of MSP008-22 excreted in urine)	72 hours post dose
Secondary	Ae %dose	(the percent of MSP008-22 recovered in urine)	72 hours post dose
Secondary	CLr	(and the apparent renal clearance of MSP008-22)	72 hours post dose