A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Biological: Dose level (DL)1; Biological: DL2; Biological: DL3; Biological: DL4; Biological: DL5

• Registration Number: NCT07042100
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

This is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.

Detailed Description

This study has two parts. In Part 1, the goal to evaluate the safety and tolerability along with the highest dose that can be tolerated, or the dose(s) which can be chosen for further evaluation. In Part 2, the focus is on evaluating the safety of SBO-154 in specific types of advanced cancers.

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-27
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2028-08
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

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 (in the Investigator's opinion), and be accessible for follow-up.
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.

Exclusion Criteria

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 examination.
3. Known or suspected history of significant drug abuse as judged by the Investigator.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SBO-154	Dose level (DL)1	-
SBO-154	DL2	-
SBO-154	DL3	-
SBO-154	DL4	-
SBO-154	DL5	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities	Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)	Applicable to Part 1 only
Incidence of treatment-related serious adverse events	Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Incidence of treatment-related adverse events	Throughout the study: from the start of study drug to 30 days post the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
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)	Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.
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)	Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.
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)	Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.
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)	Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.
To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1)	Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.
Incidences of anti-drug antibodies (ADA)	Survival Follow-up: Upto 1 yr
Incidences of titer antibodies	Survival Follow-up: Upto 1 yr
Incidences of neutralizing antibodies	Survival Follow-up: Upto 1 yr

Trial Locations

Locations (1)

SPARC Investigative Site; 🇮🇳 Delhi, New Delhi, India