Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants with Advanced Solid Tumors

Conditions

Advanced Solid Tumors

Brief summary

Incidence and severity of treatment-emergent adverse events (TEAEs), Dose and schedule based on safety, PK, pharmacodynamic, and available efficacy data

Detailed description

Plasma concentrations of RP-1664 with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination half life (t1/2), fraction excreted in urine (for food effect participants only) and other parameters as appropriate, Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or International Neuroblastoma Response Criteria (INRC; for participants with neuroblastoma). Overall response rate. Clinical benefit rate (CBR). Best percent change in tumor size from baseline. Progression-free survival (PFS)

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of treatment-emergent adverse events (TEAEs), Dose and schedule based on safety, PK, pharmacodynamic, and available efficacy data	—

Secondary

Measure	Time frame
Plasma concentrations of RP-1664 with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination half life (t1/2), fraction excreted in urine (for food effect participants only) and other parameters as appropriate, Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or International Neuroblastoma Response Criteria (INRC; for participants with neuroblastoma). Overall response rate. Clinical benefit rate (CBR). Best percent change in tumor size from baseline. Progression-free survival (PFS)	—

Measure

Time frame

Plasma concentrations of RP-1664 with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination half life (t1/2), fraction excreted in urine (for food effect participants only) and other parameters as appropriate, Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or International Neuroblastoma Response Criteria (INRC; for participants with neuroblastoma). Overall response rate. Clinical benefit rate (CBR). Best percent change in tumor size from baseline. Progression-free survival (PFS)

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Countries

Denmark

Outcome results