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An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors

ConditionAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRepertoire Immune Medicines

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.

At least one measurable lesion per RECIST v1.1 as assessed by the investigator.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Adequate organ function as defined in the trial protocol.

Disqualifiers

History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.

Known active leptomeningeal disease or uncontrolled central nervous system metastases.

Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.

Prior allogenic organ transplantation

Trial design

Design model

Sequential

Treatments tested in this trial

  • RPTR-1-201

    Drug

    RPTR-1-201

  • PD-1 / PD-L1 monoclonal antibody

    Drug

    PD-1/PD-L1 monoclonal antibody

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: MonotherapyExperimental treatment 1 intervention
Group B: CombinationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number 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.
2

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).

Secondary outcomes

1

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
2

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).
3

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).
4

Overall survival (OS)

Time from first dose of RPTR-1-201 to death from any cause.

Time frame
From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Repertoire Immune Medicines

Lead sponsor

Source ClinicalTrials.gov
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