Health TrialsbyHealthPanel

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

ConditionsNSCLCSCLCCRPCESCCOvarian CarcinomaAMLMFMalignant Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacobio Pharmaceuticals Co., Ltd.

About this trial

This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study.

These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.

Subjects with recurrent/refractory AML according to WHO 2016

Disqualifiers

History (≤3 years) of cancer that is histologically distinct from the cancer under study.

Known serious allergy to investigational drug or excipients

Active brain or spinal metastases

History of pericarditis or Grade ≥2 pericardial effusion

Trial design

Design model

Sequential

Treatments tested in this trial

  • JAB-8263

    Drug

    Variable dose, orally Q2D with 28 days each cycle

  • JAB-8263

    Drug

    RP2D dose, orally Q2D with 28 days each cycle

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: JAB-8263 Part1Experimental treatment 1 intervention
Group B: JAB-8263 Part 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with dose limiting toxicities

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-8263

Time frame
Approximately 18 months

Secondary outcomes

1

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, cardiac imaging and ophthalmological assessments

Time frame
Approximately 18 months
2

Area under the curve

Area under the plasma concentration time curve of JAB-8263

Time frame
Approximately 18 months
3

Cmax

Highest observed plasma concentration of JAB-8263

Time frame
Approximately 18 months
4

Tmax

Time of highest observed plasma concentration of JAB-8263

Time frame
Approximately 18 months

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
Apply now