Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity
| Group | Value (Participants) |
|---|---|
| Cohort 1 | 2 |
| Cohort 2 | 1 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this clinical research study is to find the appropriate dose of LL37 that can be given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the immune system to help control the disease.
Experimental
Intra-Tumoral Injection of LL37
LL37 administered intratumorally in cutaneous or subcutaneous tumors at least 1 cm in diameter. Patients will receive weekly intratumoral injections of LL37 for up to 8 weeks. The injections will be given every 7 days (+/- 48 hours). Starting dose 250 µg/tumor.
Outcomes the sponsor listed as primary.
Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity
Time frame · once a week, up to 8 weeks duration
Dose Limiting Toxicity defined as: a. Any grade 3 or 4 non-hematologic toxicity regardless of duration, except: Grade 3 skin reactions at injection sites - Grade 3 fever b. Grade 4 thrombocytopenia c. Grade 4 neutropenia lasting \>2 weeks or associated with infection.
Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37
Time frame · Radiologic evaluations in the form of CT scans of affected disease sites will be performed every 8 weeks (+/- 14 days) while on study, up to 1 year
Response defined as experiencing either an immune-related complete or partial response (irCR or irPR), and the association between response and disease characteristics and T-cell responses will be assessed using logistic regression.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Cohort 1 | 2 |
| Cohort 2 | 1 |
| Group | Value (Participants) |
|---|---|
| Cohort 1 | 2 |
| Cohort 2 | 1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cohort 1This cohort received starting dose of 250 ug/tumor injection once a week | 0 / 2 | 0 / 2 | 2 / 2 |
| Cohort 2This cohort received 500 ug/tumor injection once a week | 0 / 1 | 0 / 1 | 1 / 1 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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