Health TrialsbyHealthPanel

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacobio Pharmaceuticals Co., Ltd.

About this trial

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent.

Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).

ECOG performance status score of 0 or 1.

Has been treated with at least one line of systemic therapy for that tumor type and stage.

Disqualifiers

Active brain or spinal metastases or primary CNS tumor.

Active infection requiring systemic treatment within 7 days.

Active HBV or HCV.

Any severe and/or uncontrolled medical conditions.

Trial design

Design model

Sequential

Treatments tested in this trial

  • JAB-30355

    Drug

    Oral administration

  • JAB-30355

    Drug

    Oral administration

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Dose escalation phaseExperimental treatment 1 intervention
Group B: Dose expansion phaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

Number and proportion of participants who experience at least one dose limiting toxicity (DLT)

Time frame
Approximately one year
2

Number of participants with adverse events

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.

Time frame
Approximately three years

Secondary outcomes

1

Peak Plasma Concentration (Cmax)

Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

Time frame
Approximately three years
2

Time to reach the observed maximum (peak) concentration (Tmax)

Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

Time frame
Approximately three years
3

Terminal half-life (t1/2)

Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

Time frame
Approximately three years
4

Objective response rate (ORR)

ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Time frame
Approximately three years

Other outcomes

Sponsors and contacts

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

Jacobio Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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