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SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in participants with advanced solid tumors. Dose escalation will occur using a modified accelerated titration design (ATD).
All participants will receive SNB 101 in different cohorts. SNB 101 will be administered intravenously to participants on day 1 and day 15 of each 28 day treatment cycle until progressive disease, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
A Safety Review Committee will determine dose escalation, de-escalation, and modification and the MTD/RP2D based on DLTs and other safety information.
Each participant will undergo a screening period, a treatment period, and a follow-up period. Participants will be followed until death, withdrawal of consent, or end of study, whichever occurs first.
During the treatment period, participants will receive SNB-101 (dose range: 5 mg/m2 to 50 mg/m2) intravenously on day 1 and day 15 of each 28 day cycle.
Dose reductions are permitted after the DLT observation period, which occurs during the first 28 days of treatment (cycle 1). Participants may permanently or temporarily (at the investigator's discretion) discontinue SNB-101. If a participant experiences a DLT or unacceptable toxicity, SNB-101 treatment should be interrupted until the observed toxicity returns to baseline or ≤ grade 1 toxicity. The start of the next cycle can be delayed up to 2 weeks at the investigator's discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | SNB-101 5/8mg/m2 Q2W IV |
|
| Cohort 2 | Experimental | SNB-101 10/16mg/m2 Q2W IV |
|
| Cohort 3 | Experimental | SNB-101 20/32mg/m2 Q2W IV |
|
| Cohort 4 | Experimental | SNB-101 30/48mg/m2 Q2W IV |
|
| Cohort 5 | Experimental | SNB-101 40/64mg/m2 Q2W IV |
|
| Cohort 6 | Experimental | SNB-101 45/72mg/m2 Q2W IV |
|
| Cohort 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNB-101 | Drug | SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity(DLT) |
| up to 18 months(depending on safety variable) |
| Permanent discontinuation of SNB-101 and dose reduction due to adverse events(AEs) | Definition of permanent discontinuation of SNB-101:
| up to 18 months(depending on safety variable) |
| Number of participants with clinically meaningful changes in Laboratory test results from baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve(AUC) | - The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| Maximum plasma concentration(Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joohang Kim, Dr | CHA Medical Center at Bundang | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea | ||
| The Severance Hospital of the Yonsei University |
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1-7 cohorts, dose escalation method according to modified accelerated titration design
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SNB-101 50/80mg/m2 Q2W IV |
|
|
| up to 18 months(depending on safety variable) |
| Number of participants with clinically meaningful changes in Vital signs from baseline |
| up to 18 months(depending on safety variable) |
| Electrocardiogram(ECG) results |
| up to 18 months(depending on safety variable) |
| Number of clinically significant Chest radiograph findings(chest x-ray, CXR) |
| up to 18 months(depending on safety variable) |
- The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
| 4 months |
| Time to Cmax(Tmax) | The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| Clearance(CL) | The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| Volume of distribution(Vd) | The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| Terminal half-life(t1/2) | The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| Elimination rate constant | The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples. | 4 months |
| The objective response rate(ORR) |
| up to 18 months(depending on subject cycles) |
| Disease control rate(DCR) |
| up to 18 months(depending on subject cycles) |
| Overall survival(OS) |
| up to 18 months(depending on subject cycles) |
| Progression-free survival(PFS) |
| up to 18 months(depending on subject cycles) |
| Time to progression(TTP) |
| up to 18 months(depending on subject cycles) |
| Seoul |
| Seoul |
| 03722 |
| South Korea |
| The Catholic University of Korea Seoul ST. Mary's Hospital | Seoul | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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