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New cancer drug SBO-154 enters human testing for advanced tumors

NCT ID NCT07042100

Disease control Sponsor: Sun Pharma Advanced Research Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This early-phase trial tests a new biologic drug called SBO-154 in 177 people with advanced solid tumors that have not responded to or cannot tolerate standard treatments. The main goals are to check safety, find the right dose, and get a first look at whether the drug can shrink tumors. Participants receive the drug by IV every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SBO-154 (a biologic drug given intravenously every 3 weeks)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors who have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety, not proof of effectiveness. The drug may not shrink tumors or could cause side effects. Success is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 177 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • All India Institute for Medical Sciences

    RECRUITING

    Delhi, New Delhi, 110029, India

  • Amrita Institute of Medical Sciences

    NOT_YET_RECRUITING

    Ernākulam, Kerala, 682041, India

  • Cancer Research South Australia

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Honorhealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hope and Healing Clinical Research LLC

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Kainos Super Speciality Hopsital

    NOT_YET_RECRUITING

    Rohtak, Haryana, 124001, India

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Noble Hospital Pvt. Ltd.

    RECRUITING

    Pune, Maharashtra, 411013, India

  • Pacific Medical College and Hospital

    RECRUITING

    Udaipur, Rajasthan, 313001, India

  • S.P. Medical College and AG of Hospitals

    NOT_YET_RECRUITING

    Bikaner, Rajasthan, 334003, India

  • Sarcoma Oncology Research Center

    RECRUITING

    Santa Monica, California, 90403, United States

  • Scientia Clinical Research

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Sir H.N Reliance Foundation Hospital

    NOT_YET_RECRUITING

    Mumbai, Maharashtra, 400004, India

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, 4557, Australia

  • Tata Memorial hospital

    RECRUITING

    Mumbai, Maharashtra, 400012, India

  • Yale University - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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