FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065728 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study of ISB 2001 in Relapsed/Refractory Multiple Myeloma  
Scientific Title of Study   A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects with Relapsed/Refractory Multiple Myeloma. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Protocol No: ISB 2001-101; Version 3.0: Date: 06 Aug 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Veena Gupta 
Designation  General Manager 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) Mumbai

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  919650915109  
Fax    
Email  veena.gupta@iginnovate.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr. Veena Gupta 
Designation  General Manager 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) Mumbai

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  919650915109  
Fax    
Email  veena.gupta@iginnovate.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Jatin Kadam 
Designation  Deputy General Manager-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  918879438481  
Fax    
Email  Jatin.kadam@iginnovate.com  
 
Source of Monetary or Material Support  
Ichnos Sciences SA; Chemin de la Combeta 5 La Chaux-de-Fonds, NE 2300 CH, Switzerland  
 
Primary Sponsor  
Name  Ichnos Sciences SA 
Address  Chemin de la Combeta 5, La Chaux-de-Fonds, NE 2300 CH, Switzerland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Glenmark Pharmaceuticals Ltd  B/2, Mahalaxmi Chambers 22, Bhula Bhai Desai Road Mumbai 400026 
 
Countries of Recruitment     Australia
India
United States of America  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Padmaja Lokireddy  Apollo Cancer Centres  1st Floor, Auditorium Building, Apollo Health City, Jubilee Hills, Hyderabad, Telangana -500033
Hyderabad
TELANGANA 		 9553077700

drloki2002@yahoo.com 
Dr Rakesh Reddy Boya  Apollo Hospital  Health City, Arilova, Chinagadhilli, Vishakhapatnam 530040
Visakhapatnam
ANDHRA PRADESH 		 9013355935

drrakeshreddyboya@gmail.com 
Dr Velu Nair  Apollo Hospital  Plot No 1a, GIDC Estate, Bhat, Gandhinagar, Gujarat-382428
Gandhinagar
GUJARAT 		 9818256670

nairvelu2000@yahoo.com 
Dr Balasaheb Wanve  Asian institute of gastroenterology  No 136, Plot no 2/3/4/5, Mindspace Road, Gachibowli, Hyderabad, Telangana-500032
Hyderabad
TELANGANA 		 8452992935

dr.wanvebalasaheb@aighospitals.com 
Dr Sameer Melinkeri  Deenanath Mangeshkar Hospital  Onco Research room, 1st floor annex Building, Deenanath Mangeshkar Hospital, Erandwane, Pune -411004
Pune
MAHARASHTRA 		 9766249644

docmelinkeri@yahoo.com 
Dr Nataraj KS   Healthcare Global Enterprises Limited  8, HCG Towers, P Kalinga Rao Road, Sampangi Ram Nagar, Bengaluru 560027
Bangalore
KARNATAKA 		 9482141773

drnataraj.ks@hcgel.com 
Dr Vijay Patil  P. D. Hinduja Hospital & Medical Research Centre  Khar Facility, Marvella Building, 724, 11th Rd, Khar West, Mumbai,400052
Mumbai
MAHARASHTRA 		 9136129135

vijaypgi@gmail.com 
Dr Ghanshyam Biswas  Sparsh Hospital & Critical Care Pvt Ltd  A/407, Saheed Nagar, Bhubaneswar, Odisha-751007
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr Ashay Karpe  Sunact Cancer Institute Pvt. Ltd  4th floor, Tieten Medicity Hospital, Kasarvadavali, Ghodbunder Road, Thane 400615
Thane
MAHARASHTRA 		 9029083054

ashayoncology@gmail.com 
Dr Bhausaheb P Bagal  Tata Memorial Centre  Dr E. Borges road, Parel, Mumbai - 400012 
Mumbai
MAHARASHTRA 		 02224177210

bagalbp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Asian institute of gastroenterology  Submittted/Under Review 
Clinical Studies Apollo Hospitals Enterprise Limited  Approved 
clinical Studies Apollo Hospitals International Ltd.  Approved 
Institutional Ethics Committee - Deenanth Mangeshkar Hospital & Research center  Approved 
Institutional Ethics Committee - Tata Memorial Hospital  Submittted/Under Review 
Institutional Ethics Committee, P D Hinduja Hospital and Medical Research Centre  Submittted/Under Review 
Institutional Ethics Committee-Clinical Studies Apollo Hospital  Approved 
Institutional Ethics Committee-HCG Central Ethics Committee  Approved 
Sparsh Hospital & Critical Care Pvt Ltd  Approved 
Vedant Hospital Institutional Ethic Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C900||Multiple myeloma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ISB 2001  Dosage Form: Lyophilized powder for solution for injection Unit Strength: Each vial delivers 77 mg of ISB 2001 Dosage Frequency: Cycle 1: Step-up doses on Days 1 and 4 in Cycle 1 followed by dosing on Days 8, 15, 22 Cycle 2 onwards: Weekly, dosing on Days 1, 8, 15, and 22 of each 28-day treatment cycle Mode of Administration: Subcutaneous injection(s) 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24-hour urine, serum-free light chains or measurable isolated plasmacytoma.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
3. Must have adequate hematologic, hepatic, renal, and cardiac functions. 
 
ExclusionCriteria 
Details  1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
2. Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1) 		 1. [Time Frame: Up to 18 months]
2. [Time Frame: Up to 28 days] 
 
Secondary Outcome  
Outcome  TimePoints 
Maximum Concentration (Cmax) of ISB 2001 in Serum   [Time Frame: Up to 28 days] 
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum   [Time Frame: Up to 28 days] 
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum   [Time Frame: Up to 28 days] 
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum  [Time Frame: Up to 28 days] 
Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)  [Time Frame: Baseline to 18 months] 
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)  [Time Frame: 18 months] 
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)  [Time Frame: 18 months] 
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)  [Time Frame: 18 months] 
Time to Progression (TTP)  [Time Frame: 18 months] 
Time to Next Treatment (TTNT)  [Time Frame: 18 months] 
Time to Response (TTR)  [Time Frame: 18 months] 
Progression Free Survival (PFS)  [Time Frame: 18 months] 
Overall Survival (OS)   [Time Frame: 18 months] 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/08/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

The study will enroll participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.

The study will be conducted in two phases:

Part 1: Dose escalation phase

Part 2: Dose expansion phase

Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose at each putative recommended Phase 2 dose(s). Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study. 
Close