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CTRI Number  CTRI/2022/06/043504 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   SAD, Phase I Trial to Assess Safety, Tolerability and PK Profile of MSP008-22 in Patients With Advanced Solid Tumours 
Scientific Title of Study   A Single Ascending Dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetic Profile of MSP008-22 in Patients with Advanced Solid Tumours 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Clinexel-GBL-002 Version 1.1 dated 18 Sep 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Salil Vijay Patkar 
Designation  Principal Investigator 
Affiliation  K.J. Somaiya Hospital & Research Center 
Address  Department of Oncology
Somaiya Ayurvihar, Eastern Express Hwy, Sion East, Sion
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  08451069854  
Fax    
Email  salilvpatkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Arora 
Designation  Director-Clinexel Life Sciences Private Limited  
Affiliation  Clinexel Life Sciences Private Limited  
Address  Office No. 702, The Affaires, Palm Beach Road Sector 17, Sanpada

Thane
MAHARASHTRA
400705
India 
Phone  09820648395   
Fax    
Email  deepaarora@clinexel.com  
 
Details of Contact Person
Public Query  
Name  Dr Sangeeta Srivastava 
Designation  Executive Director and Head R & D 
Affiliation  Godavari Biorefineries Ltd. 
Address  Somaiya Bhavan, 45-47
Mahatma Gandhi Road, Post Box No. 384, Fort
Mumbai
MAHARASHTRA
400001
India 
Phone  09820342002  
Fax    
Email  sangeeta@somaiya.com  
 
Source of Monetary or Material Support  
Godavari Biorefineries Limited, Somaiya Bhavan, 45-47, Mahatma Gandhi Road, Post Box No. 384, Fort, Mumbai-Maharashtra 400 001 
 
Primary Sponsor  
Name  Godavari Biorefineries Limited 
Address  Somaiya Bhavan, 45-47, Mahatma Gandhi Road, Post Box No. 384, Fort, Mumbai-Maharashtra 400 001 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath Nookala Krishnamurthy  Advanced Centre for Treatment Research and Education in Cancer  Room No. 102 Khanolkar Shodhika Building ACTREC Sec22 Kharghar
Mumbai
MAHARASHTRA 		 9920703438

nk.manjunath@gmail.com 
Dr Mohsin Khan  Jawaharlal Nehru Medical College and Hospital  Faculty of Medicine Aligarh Muslim University
Aligarh
UTTAR PRADESH 		 9412731835

mohdtabish7500@gmail.com 
Dr Amit Gupta  K. J Somaiya Hospital and Research Centre  Department of Oncology, Somaiya Ayurvihar, Eastern Express Hwy, Sion East, Sion,
Mumbai (Suburban)
MAHARASHTRA 		 9833275115

doctoramit73@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital  Approved 
Institutional Ethics Committee, K J Somaiya Medical College and Research Centre, Mumbai   Approved 
Institutional Ethics committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MSP008-22  Total 05 doses of MSP008-22 in the form of oral dose formulation are selected for the trial.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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,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 ≥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.


 
 
ExclusionCriteria 
Details  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) 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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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] 		 30 days post dose
 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacokinetic profile of MSP008-22
Estimation of plasma and urine pharmacokinetic profile of MSP008-22
[Time Frame: 72 hours post dose 		 72 hrs 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/07/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. The current 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 (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).
 
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