| CTRI Number |
CTRI/2025/09/095114 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Cancers. |
|
Scientific Title of Study
|
A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SBO-154-25-01; Version: Amendment 2 (A2) dated 28-Apr-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President, Product Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9102266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President, Product Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9102266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President, Product Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9102266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Limited
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E) Mumbai
Mumbai
MAHARASHTRA
400093
India |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Limited |
| Address |
Sun Pharma Advanced Research Company Limited, Plot No. 5 & 6/1, Savli GIDC Estate, Manjusar, Vadodara (India) – 391775 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
India
United States of America |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer Rastogi |
All India Institute for Medical Sciences |
Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar
New Delhi
DELHI |
9958975343
samdoc_mamc@yahoo.com |
| Dr Minish Jain |
Noble Hospital Pvt. Ltd. |
Noble Hospital Pvt. Ltd., 153, Magarpatta City Road, Hadapsar,
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Kumar Prabash |
Tata Memorial hospital, Mumbai |
Dr. E Borges Road, Homi-Bhabha building, Room No. 1108, Parel
Mumbai
MAHARASHTRA |
9167760576
kprabhash1@gmail.com |
| Dr Kumar Prabash |
Tata Memorial hospital, Mumbai |
Dr. E Borges Road, Homi-Bhabha building, Room No. 1108, Parel
Mumbai
MAHARASHTRA |
9958975343
kprabhash1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics committee I, Tata Memorial Hospital |
Approved |
| Institutional Ethics committee II, Tata Memorial Hospital |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SBO-154 |
Administered intravenously at a dose ranging from 0.3-2.5mg/kg once every 3 weeks as long as a subject continues to derive clinical benefit from the study or discontinues the study due to any reason. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to give written and dated, informed consent (or legally acceptable representative/ impartial witness when applicable) and is available for the entire study.
2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions and be accessible for followup.
3. Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no standard treatment is available
4. Has a life expectancy of 3 months or more |
|
| ExclusionCriteria |
| Details |
1. Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical.
3. Known or suspected history of significant drug abuse as judged by the Investigator examination.
4. Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
5. Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
6. Positive exclusion tests: urine pregnancy tests (if applicable), serology tests positive for HIV, HCV, HBsAg (unless they are considered subjects with resolved Hepatitis B and C infection.
7. History of any relevant allergy/ hypersensitivity including known immediate or delayed hypersensitivity reaction or idiosyncrasy to biological agents or drug chemically related to SBO-154 or its excipients.
8. Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of dose-limiting toxicities (Applicable to Part 1 only)
2. Incidence of treatment-related serious adverse events
3. Incidence of treatment-related adverse events |
From baseline until 30 days after last dose of SBO-154 or longer if required |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the overall response rate (i.e., the percentage of participants who achieved a best response of Complete Response (CR) or Partial Response (PR), per RECIST v1.1) |
From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154 |
| To evaluate the duration of response (i.e., the time from the initial response (CR or PR) to the time of progression of disease (PD) or death, per RECIST v1.1) |
From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154
|
| To evaluate the disease control rate (i.e., the percentage of participants who achieved a best response of CR, PR, or remained stable disease (SD), per RECIST v1.1) |
From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154 |
| To evaluate the time to response (i.e., the time from treatment start to the time-point where a best response of CR or PR was achieved, per RECIST v1.1) |
From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154
|
| To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1) |
From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154 |
| Incidences of ADA, titer and neutralizing antibodies |
Survival Follow-up: Upto 1 yr |
|
|
Target Sample Size
|
Total Sample Size="177"
Sample Size from India="95"
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)
Modification(s)
|
14/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
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 is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not responded to previous treatment with standard therapy available in the country. The study involves multiple doses and takes place at several centers. |