Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ASP9801 · 1 trial · 3 indications
Incidence of dose limiting toxicities
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Number of participants with potentially clinically significant laboratory values.
Number of participants with potentially clinically significant vital sign values.
12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation - cutaneous or subcutaneous lesions | EXPERIMENTAL | Participants will receive ASP9801 (1x10\^7 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Escalation - visceral lesions | EXPERIMENTAL | Participants will receive ASP9801 (1x10\^8 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions | EXPERIMENTAL | Participants will receive ASP9801 (1x10\^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy) - visceral lesions | EXPERIMENTAL | Participants will receive ASP9801 (5x10\^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions | EXPERIMENTAL | Participants will receive ASP9801 (5x10\^8 pfu/mL) on days 1, 8, 15 and 22 of the first 28 day cycle. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions | EXPERIMENTAL | Participants will receive ASP9801 (1x10\^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions | EXPERIMENTAL | Participants will receive ASP9801 (5x10\^8 pfu/mL) on days 1, 8, 15 and 22 of first 28 day cycle at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Therapy) - visceral lesions | EXPERIMENTAL | Participants will receive ASP9801 (5x10\^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| ASP9801 | BIOLOGICAL | Administered by intratumoral injection |
| Pembrolizumab | COMBINATION_PRODUCT | Administered by Intravenous Infusion |
Inclusion Criteria: * Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s). * Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratum...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |