Advanced Solid TumorsPhase 1NCT07042100
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
A Phase 1 study testing Dose level (DL)1, DL2 and DL3 in people with Advanced Solid Tumors, run by Sun Pharma Advanced Research Company Limited at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Dose level (DL)1, DL2 and DL3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 12 Aug 2025to Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- Has a life expectancy of ≥3 months.
Who cannot join
- Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
- Known or suspected history of significant drug abuse as judged by the Investigator.
- Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
- 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).
- 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.
- Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
India8 sites, 8 recruiting
- Not yet recruiting
S.P. Medical College and AG of Hospitals
Bikaner, Rajasthan, 334003
Surender Beniwal, MD, DM Medical Oncology, 9414370484, beniwal.surendra@gmail.com
- Recruiting
All India Institute for Medical Sciences
Delhi, New Delhi, 110029
Sameer A Rastogi, MD, 9958975343, samdoc_mamc@yahoo.com
- Not yet recruiting
Amrita Institute of Medical Sciences
Ernākulam, Kerala, 682041
Wesley Jose, MD, 8281928375, wesleymjose@aims.amrita.edu
- Not yet recruiting
Sir H.N Reliance Foundation Hospital
Mumbai, Maharashtra, 400004
Sewanti Limaye, MD, 9619607339, Sewanti.Limaye@rfhospital.org
- Recruiting
Tata Memorial hospital
Mumbai, Maharashtra, 400012
Prabash Kumar, MD, 9167760576, kprabhash1@gmail.com
- Recruiting
Noble Hospital Pvt. Ltd.
Pune, Maharashtra, 411013
Minish M Jain, MD, 9823133390, minishjain009@gmail.com
- Not yet recruiting
Kainos Super Speciality Hopsital
Rohtak, Haryana, 124001
Keshav Garg, MD, 9729179012, garg484keshav@gmail.com
- Recruiting
Pacific Medical College and Hospital
Udaipur, Rajasthan, 313001
Manoj U Mahajan, MD, 9818051316, drmanoj.mahajan@gmail.com
United States5 sites, 5 recruiting
- Recruiting
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, 60521
Srilata Gundala, MBBS, 630-560-0121, sgundala@hopenheal.care
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ecaterina Dumbrava, MD, 713-792-3934, eeileana@mdanderson.org
- Recruiting
Yale University - Yale Cancer Center
New Haven, Connecticut, 06510
So Y Kim, MD, 203-407-8002, soyeon.kim@yale.edu
- Recruiting
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Neil S Chawla, MD, 310-552-9999, schawla@sarcomaoncology.com
- Recruiting
Honorhealth Research Institute
Scottsdale, Arizona, 85258
Justin Moser, MD, MBA, 480-323-1350, ssharma@honorhealth.com
Australia3 sites, 3 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, 5000
Sarwan K Bishnoi, MBBS, 08 8359 2565, sbishnoi@adelaidecancercentre.com.au
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4557
Andrew L Schmidt, MBBS, 754377633, andrew.schmidt@uqconnect.edu.au
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Joe Wei, MD, 293825873, joe.wei@scientiaclinicalresearch.com.au
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- Dose level (DL)1, DL2, DL3, DL4, DL5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose level (DL)1Biological
Administered IV every 3 weeks
DL2Biological
Administered IV every 3 weeks
DL3Biological
Administered IV every 3 weeks
DL4Biological
Administered IV every 3 weeks
DL5Biological
Administered IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| SBO-154 | Experimental | Not described Receives: Biological: Dose level (DL)1; Biological: DL2; Biological: DL3; Biological: DL4; Biological: DL5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities
Applicable to Part 1 only
Measured: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)
Incidence of treatment-related serious adverse events
Measured: 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
Measured: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Survival Follow-up: Upto 1 yr
Incidences of titer antibodies
Measured: Survival Follow-up: Upto 1 yr
Incidences of neutralizing antibodies
Measured: Survival Follow-up: Upto 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start12 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042100
- Sponsor's protocol ID
- SBO-154-25-01
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07042100
- Acronym / sponsor ID
- SBO-154-25-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBO-154 | Experimental | Biological: Dose level (DL)1, Biological: DL2, Biological: DL3, Biological: DL4, Biological: DL5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
- 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.
- Has a life expectancy of ≥3 months.
Key exclusion criteria (8 listed)
- Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
- Known or suspected history of significant drug abuse as judged by the Investigator.
- Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose level (DL)1Administered IV every 3 weeks | Biological | SBO-154 |
| DL2Administered IV every 3 weeks | Biological | SBO-154 |
| DL3Administered IV every 3 weeks | Biological | SBO-154 |
| DL4Administered IV every 3 weeks | Biological | SBO-154 |
| DL5Administered IV every 3 weeks | Biological | SBO-154 |
Primary outcome
Incidence of dose-limiting toxicities
Time frame: 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
Time frame: 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
Time frame: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
8 secondary outcomes
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: 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: 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: 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: 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: 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)
Time frame: Survival Follow-up: Upto 1 yr
Incidences of titer antibodies
Time frame: Survival Follow-up: Upto 1 yr
Incidences of neutralizing antibodies
Time frame: Survival Follow-up: Upto 1 yr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose level (DL)1, DL2 and DL3 in people with Advanced Solid Tumors, run by Sun Pharma Advanced Research Company Limited at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sandeep Inamdar (91-22-66455645, clinical.trials@sparcmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (time frame: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.