Advanced Solid Tumor, Metastatic Solid Tumor
Conditions
Brief summary
Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT), 2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs), Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1
Detailed description
Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203, 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203, 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203, 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies, 5. Objective response rate (ORR), 6. Ph Ib Duration of response (DoR). DoR is defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first, 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first, for participants with SD as best response, with a minimum SD duration of 8 weeks, 8. Progression-free survival (PFS). PFS is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first., 9. Disease control rate (DCR). DCR is defined as the percentage of participants with BOR of CR, PR, or SD, as determined by investigator per RECIST version 1.1, from the first IPN01203 administration throughout the study., 10. Time to response (TTR). TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1., 11. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT), 2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs), Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203, 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203, 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203, 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies, 5. Objective response rate (ORR), 6. Ph Ib Duration of response (DoR). DoR is defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first, 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first, for participants with SD as best response, wit | — |
Countries
France, Spain