Advance solid tumors
Conditions
Brief summary
Part 1 and 2: • TEAEs • DLTs • Laboratory parameters • Vital signs • ECGs • MTD (or MAD) and RDE of IMP1734 as monotherapy and in combination with anti-cancer agents, Part 3: • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1 by Investigator, and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria.
Detailed description
PK parameters derived from plasma concentration data of IMP1734 and/or metabolites (if applicable) following single oral dose: • Cmax, Tmax, AUC0-t, AUC0-tau, Cmax(dn), and AUC0-tau(dn) • If data permit, AUC0-inf, CL/F, Vd/F, and t1/2, PK parameters derived from plasma concentration data of IMP1734 and/ormetabolites (if applicable) following multiple oral doses: • Cmax,ss, Ctrough, Tmax,ss, AUC0-t,ss, AUC0-tau,ss, Cmax,ss(dn), AUC0-tau(dn), Rac-Cmax,ss and Rac-AUC0-tau,ss, • If data permit, CL/F, Vd/F, and t1/2 • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1, by Investigator and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria., • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of participants who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with BOR of CR, PR or lasting ≥ 18 weeks of SD after the start of the study drug, • PFS • OS • For prostate cancer only: o PSA response per PCWG3 criteria o PSA progression o PSA complete response rate, Part 3: • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of patients who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with BOR of CR, PR or lasting ≥ 18 weeks of SD after the start of the study drug, Part 3:• PFS • OS • For prostate cancer only: o PSA response per PCWG3 criteria o Time to PSA progression, • TEAEs • Laboratory parameters • Vital signs • ECGs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and 2: • TEAEs • DLTs • Laboratory parameters • Vital signs • ECGs • MTD (or MAD) and RDE of IMP1734 as monotherapy and in combination with anti-cancer agents, Part 3: • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1 by Investigator, and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters derived from plasma concentration data of IMP1734 and/or metabolites (if applicable) following single oral dose: • Cmax, Tmax, AUC0-t, AUC0-tau, Cmax(dn), and AUC0-tau(dn) • If data permit, AUC0-inf, CL/F, Vd/F, and t1/2, PK parameters derived from plasma concentration data of IMP1734 and/ormetabolites (if applicable) following multiple oral doses: • Cmax,ss, Ctrough, Tmax,ss, AUC0-t,ss, AUC0-tau,ss, Cmax,ss(dn), AUC0-tau(dn), Rac-Cmax,ss and Rac-AUC0-tau,ss, • If data permit, CL/F, Vd/F, and t1/2 • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1, by Investigator and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria., • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of participants who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with | — |
Countries
Denmark, France, Spain