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CTRI Number  CTRI/2024/04/065308 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to assess safety, tolerability, and anticancer activity of ISB 1442 
Scientific Title of Study   A Phase 1/2, First-in-Human, Multicentre, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: ISB 1442-101; Version No 3.1; Dated 19-Oct-2023  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
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  Glenmark Research Centre, 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 Glenmark House B D Sawant Marg  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) Mumbai 
 
Countries of Recruitment     United States of America
Australia
India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uday Prakash Kulkarni   Christian Medical College  Ranipet Campus, Department of haematology, A 501, A Block 5th Floor, Kilminnal Village
Vellore
TAMIL NADU 		 914172224553

kulkarni.uday@cmcvellore.ac.in 
Dr Sameer Melinkeri  Deenanath Mangeshkar Hospital  Onco Research room, 1st floor annex Building, Deenanath Mangeshkar Hospital, Erandwane
Pune
MAHARASHTRA 		 9766249644

docmelinkeri@yahoo.com 
Dr Nataraj KS  HCG Cancer Centre Bangalore  Health care Global Enterprises Limited, Senior Consultant Hemato Oncologist, HCG Towers 4 5th floor, No. 8 P Kalinga Rao Road, Sampangi Rama Nagar
Bangalore
KARNATAKA 		 9482141775

drnataraj.ks@hcgel.com 
Dr Tapan Kumar Saikia  Jaslok Hospital and Research Centre  Jaslok Hospital and Research Centre, 15, Dr.G Deshmukh Marg: 400026
Mumbai (Suburban)
MAHARASHTRA 		 02266573232

tapan.saikia@gmail.com 
Dr Santhosh Kumar Devadas  M S Ramaiah Clinical research centre  1st floor, M S Ramaiah advance learning centre, M S Ramaiah nagar, MSRIT POST, Bangalore-560054.
Bangalore
KARNATAKA 		 9036939296

drsanthoshkumar28@gmail.com 
Dr Rayaz Ahmed Khalid  Max Super Speciality Hospital  Saket A unit of Devki Devi Foundation), 2, Press Enclave Road, Saket, New Delhi,110017
New Delhi
DELHI 		 8826033518

Rayaz.Khalid@maxhealthcare.com 
Dr Vijay Patil  P. D. Hinduja Hospital & Medical Research Centre  Khar Facility, Marvella Building, 724, 11th Rd, Khar West: 400052
Mumbai (Suburban)
MAHARASHTRA 		 9136129135

vijaypgi@gmail.com 
Dr Dinesh Bhurani  Rajiv Gandhi Cancer Institute & Research Center  Department of Hemato-Oncology & BMT Unit, Rajiv Gandhi Cancer Institute & Research Centre, D-18, Sector-5, Rohini, New Delhi
New Delhi
DELHI 		 011-4702-2261

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

bagalbp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee - M.S. Ramaiah Medical College and Hospitals  Approved 
Ethics committee- Jaslok Hospital  Research Centre  Approved 
Institutional Ethics Committee - Deenanth Mangeshkar Hospital & Research center  Approved 
Institutional Ethics Committee - Devki Devi foundation  Approved 
Institutional Ethics Committee - Tata Memorial Hospital  Approved 
Institutional Ethics Committee, P D Hinduja Hospital and Medical Research Centre  Approved 
Institutional Ethics Committee- Christian Medical College  Approved 
Institutional Ethics Committee- HCG Central Ethics Committee  Approved 
Institutional Review Board- Rajiv Gandhi Cancer Institute & Research Centre  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 1442  Dosage Form: Lyophilized powder for solution for injection Dose: Starting dose from 6 mg. Dosage Frequency: Weekly, dosing on Days 1, 8, 15, and 22 of each 28-day treatment cycles Mode of Administration: Subcutaneous injection(s) 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients aged 18 years or older.
2. Be willing and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
3. Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients):
a) Must have received PIs, IMiDs, and anti-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefits.
b) Must have measurable M-protein (serum and/or 24-hour urine, or serum free light chains).
4. Phase 2a: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients):
Cohort A: R/R MM
a) Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
• Serum M-protein ≥ 0.5 g/dL (IgA ≥ 0.5 g/dL), or
• Urine light-chain (M-protein) of ≥ 200 mg/24 hours, or
• Serum free light chain (sFLC) assay: involved free light chain (FLC) level ≥ 10 mg/dL provided sFLC ratio is abnormal.
Cohort B: R/R MM Post-T-Cell Directed Therapy
a) Must have received PIs, IMiDs, and anti-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefits.
b) Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
• Serum M-protein ≥ 0.5 g/dL (IgA ≥ 0.5 g/dL), or
• Urine light-chain (M-protein) of ≥ 200 mg/24 hours, or
• sFLC assay: involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
5. Have a body weight ≥ 40.0 kg at screening.
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
7. Have life expectancy of at least 3 months (from date of informed consent signing).
8. Have adequate organ function, including:
a. Estimated creatinine clearance ≥45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine analysis.
b. Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 × ULN; bilirubin ≤1.5 × ULN. Patients with Gilberts syndrome may have a bilirubin level greater than 1.5 times ULN, per discussion between the Investigator and medical monitor.
9. Left ventricular ejection fraction (LVEF) ≥45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan. 
 
ExclusionCriteria 
Details  1. Patients with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
2. Participants with MM with disease where the only measurable parameter is plasmacytoma. Note: Prophylactic localized ("spot") radiation for areas of pain is allowed
3. Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 28 days of C1D1; systemic anticancer treatments within 14 days of (C1D1) or any investigational products within 5 half-lives of C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/day for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Î’ ligand inhibitors are allowed.
4. Received autologous stem cell transplantation within 12 weeks of C1D1.
5. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
6. Active malignant central nervous system involvement
7. Known to be refractory to platelet or RBC transfusions
8. Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
9. Prior radiation therapy within 14 days of C1D1 or prior irradiation to greater than 25% of the bone marrow. Note: Prophylactic localized ("spot") radiation for areas of pain is allowed.
10. QTc interval greater than 480 msec at screening using Fredericias QT correction formula. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Phase 1: Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs)
2. Phase 1: For MTD: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1) in each cohort
3. Phase 2a: Overall Response Rate (ORR) Based on investigators assessment according to International Myeloma Working Group (IMWG) 		 1. Up to 18 months
2. Up to 28 days
3. 18 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. Maximum Concentration (Cmax) of ISB 1442 in Serum  Up to 28 days 
2. Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum  Up to 28 days 
3. Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum   Up to 28 days 
4. Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum   Up to 28 days 
5. Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)  Baseline to 18 months 
Phase 1 and Phase 2a: Time to Progression (TTP)   18 Months 
7. Phase 1 and Phase 2a: Time to Next Treatment (TTNT)   18 Months 
8. Phase 1 and Phase 2a: Time to Response (TTR)  18 Months 
9. Phase 1 and Phase 2a: Progression free survival (PFS)  18 Months 
10. Phase 1 and Phase 2a: Overall survival (OS)  18 Months 
11. Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)  18 months 
12. Phase 1 and Phase 2a: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)   18 months 
13. Phase 1 and Phase 2a: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)   18 months 
14. Phase 2a: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)  18 months  
 
Target Sample Size   Total Sample Size="121"
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/ Phase 2 
Date of First Enrollment (India)   12/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/09/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
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 is a first-in-human, Phase 1/2a, open label study evaluating safety and efficacy of ISB 1442 in patients with relapsed/ refractory (R/R) multiple myeloma (MM).

Patients will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a recommended phase 2 Dose (RP2D) is established in Phase 1, Phase 2 will be initiated for that indication. The Phase 2 design uses the Simon two-stage design with stopping rules for lack of activity, as well as stopping rules for toxicity. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs. 
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