This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
RPTR-1-201
PD-1/PD-L1 monoclonal antibody
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGNumber of participants with dose-limiting toxicities and treatment-emergent adverse events.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
Time frame: From first dose through 30 days after last dose of trial treatment.
Objective Response Rate (ORR) per RECIST v1.1
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
Time frame: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Incidence and severity of adverse events and abnormal safety assessments.
Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs).
Time frame: From first dose through 30 days after last dose of trial treatment
Pharmacokinetics of RPTR-1-201
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201.
Time frame: First dose until end of treatment (assessed up to 24 months).
Progression Free Survival (PFS)
Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Overall survival (OS)
Time from first dose of RPTR-1-201 to death from any cause.
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Time frame: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time to Response
Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1.
Time frame: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Pharmacokinetics of RPTR-1-201 (AUC)
Characterization of the pharmacokinetic area under the curve of RPTR-1-201
Time frame: First dose until end of treatment (assessed up to 24 months)
Immunogenicity of RPTR-1-201
Characterization of the incidence of anti-drug antibodies of RPTR-1-201.
Time frame: First dose until end of treatment (assessed up to 24 months)