Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GAd-209-FSP low dose · 1 trial · 1 indication
Toxicity analyzed within 28-days from the administration of the prime vaccination with GAd20-209-FSP
AEs as characterized by type, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v.5.0), timing, seriousness, and relationship to study treatments.
Assessed using RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Cohort A - Dose-escalation | EXPERIMENTAL | Phase I. Part 1. Dose escalation cohort. Subjects treated with low dose or with high dose of GAd20-209-FSP prime and MVA-209-FSP boosts to define the RP2D, in combination with pembrolizumab. Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. |
| Cohort B - Expansion Cohort Phase I | EXPERIMENTAL | Phase I. Part 1. Expansion cohort at RP2D. Subjects treated with RP2D dose of GAd20-209-FSP prime and MVA-209-FSP boosts, in combination with pembrolizumab. Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors. |
| Cohort C - Expansion cohort Phase II | EXPERIMENTAL | Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatment. Subjects will be randomized with an allocation ratio 2:1 to Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy versus pembrolizumab monotherapy. |
| Cohort D - Expansion cohort Phase II | EXPERIMENTAL | Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who have had radiographic progression (PD) after having a best response of stable disease (SD) or better on/after anti-PD1 treatment. Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy. |
| Name | Type | Description |
|---|---|---|
| GAd-209-FSP low dose | BIOLOGICAL | GAd20-209-FSP IP, low dose |
| MVA-209-FSP low dose | BIOLOGICAL | MVA-209-FSP IP, low dose |
| GAd-209-FSP high dose | BIOLOGICAL | GAd20-209-FSP IP, high dose |
| MVA-209-FSP high dose | BIOLOGICAL | MVA-209-FSP IP, high dose |
| GAd20-209-FSP, RP2D | BIOLOGICAL | GAd20-209-FSP IP, RP2D |
| MVA-209-FSP, RP2D | BIOLOGICAL | MVA-209-FSP IP, RP2D |
| KEYTRUDA® | DRUG | anti-PD-1 checkpoint inhibitor (200 mg; Q3W) |
Inclusion Criteria for Cohort C (Phase II) In order to be eligible, the subject must: 1. Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study. 2. Have previously proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) sta...