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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBO-154 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose level (DL)1 | Biological | Administered IV every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities | Applicable to Part 1 only | Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandeep Inamdar | Contact | 91-22-66455645 | clinical.trials@sparcmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honorhealth Research Institute | Recruiting | Scottsdale | Arizona | 85258 | United States |
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| DL2 |
| Biological |
Administered IV every 3 weeks |
|
| DL3 | Biological | Administered IV every 3 weeks |
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| DL4 | Biological | Administered IV every 3 weeks |
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| DL5 | Biological | Administered IV every 3 weeks |
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| 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 |
| Sarcoma Oncology Research Center | Recruiting | Santa Monica | California | 90403 | United States |
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| Yale University - Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Hope and Healing Clinical Research LLC | Recruiting | Hinsdale | Illinois | 60521 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Scientia Clinical Research | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Sunshine Coast University Private Hospital | Recruiting | Birtinya | Queensland | 4557 | Australia |
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| Cancer Research South Australia | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Kainos Super Speciality Hopsital | Not yet recruiting | Rohtak | Haryana | 124001 | India |
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| Amrita Institute of Medical Sciences | Not yet recruiting | Ernākulam | Kerala | 682041 | India |
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| Sir H.N Reliance Foundation Hospital | Not yet recruiting | Mumbai | Maharashtra | 400004 | India |
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| Tata Memorial hospital | Recruiting | Mumbai | Maharashtra | 400012 | India |
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| Noble Hospital Pvt. Ltd. | Recruiting | Pune | Maharashtra | 411013 | India |
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| All India Institute for Medical Sciences | Recruiting | Delhi | New Delhi | 110029 | India |
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| Pacific Medical College and Hospital | Not yet recruiting | Udaipur | Rajasthan | 313001 | India |
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