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

NCT ID: NCT07042100

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2030-08-31

Brief Summary

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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

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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.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBO-154

Group Type EXPERIMENTAL

Dose level (DL)1

Intervention Type BIOLOGICAL

Administered IV every 3 weeks

DL2

Intervention Type BIOLOGICAL

Administered IV every 3 weeks

DL3

Intervention Type BIOLOGICAL

Administered IV every 3 weeks

DL4

Intervention Type BIOLOGICAL

Administered IV every 3 weeks

DL5

Intervention Type BIOLOGICAL

Administered IV every 3 weeks

Interventions

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Dose level (DL)1

Administered IV every 3 weeks

Intervention Type BIOLOGICAL

DL2

Administered IV every 3 weeks

Intervention Type BIOLOGICAL

DL3

Administered IV every 3 weeks

Intervention Type BIOLOGICAL

DL4

Administered IV every 3 weeks

Intervention Type BIOLOGICAL

DL5

Administered IV every 3 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Honorhealth Research Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

Sarcoma Oncology Research Center

Santa Monica, California, United States

Site Status RECRUITING

Yale University - Yale Cancer Center

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Hope And Healing Cancer Services, Llc

Hinsdale, Illinois, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Scientia Clinical Research

Randwick, New South Wales, Australia

Site Status RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

Site Status RECRUITING

Cancer Research South Australia

Adelaide, South Australia, Australia

Site Status RECRUITING

Tata Memorial hospital

Mumbai, Maharashtra, India

Site Status NOT_YET_RECRUITING

Noble Hospital Pvt. Ltd.

Pune, Maharashtra, India

Site Status RECRUITING

All India Institute for Medical Sciences

Delhi, New Delhi, India

Site Status RECRUITING

Countries

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United States Australia India

Central Contacts

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Dr. Sandeep Inamdar

Role: CONTACT

91-22-66455645

Facility Contacts

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Justin Moser, MD, MBA

Role: primary

480-323-1350

Neil S Chawla, MD

Role: primary

310-552-9999

So Y Kim, MD

Role: primary

203-407-8002

Srilata Gundala, MBBS

Role: primary

630-560-0121

Ecaterina Dumbrava, MD

Role: primary

713-792-3934

Joe Wei, MD

Role: primary

293825873

Andrew L Schmidt, MBBS

Role: primary

754377633

Sarwan K Bishnoi, MBBS

Role: primary

08 8359 2565

Prabash Kumar, MD

Role: primary

9167760576

Minish M Jain, MD

Role: primary

9823133390

Sameer A Rastogi, MD

Role: primary

9958975343

Other Identifiers

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SBO-154-25-01

Identifier Type: -

Identifier Source: org_study_id

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