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NCT Number: NCT04686682

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

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.

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Key information

Conditions

NSCLC AML Adnexal Diseases CRPC ESCC Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders MF Malignant Tumor Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms SCLC Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

About this study

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced malignant tumors. To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc).To evaluate preliminary antitumor activity of JAB-8263

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must meet all the following criteria in order to be included in the research study:
  • 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
  • Subjects with life expectancy ≥3 months.
  • Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have sufficient baseline organ function.

Exclusion criteria

  • 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
  • History of interstitial lung disease.
  • History of Grade ≥2 active infections within 2 weeks
  • Known human immunodeficiency virus (HIV) infection
  • Seropositive for hepatitis B virus (HBV)
  • Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
  • Any severe and/or uncontrolled medical conditions
  • History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
  • Impaired cardiac function or clinically significant cardiac diseases
  • QTcF >470 msec at screening
  • History of medically significant thromboembolic events or bleeding diathesis
  • Unresolved Grade >1 toxicity
  • History of malignant biliary obstruction
  • Pregnant or breast-feeding

Treatment and study plan

JAB-8263

Drug

Variable dose, orally Q2D with 28 days each cycle

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Time frame: Approximately 18 months

    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

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Approximately 18 months

    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

  2. Area under the curve

    Time frame: Approximately 18 months

    Area under the plasma concentration time curve of JAB-8263

  3. Cmax

    Time frame: Approximately 18 months

    Highest observed plasma concentration of JAB-8263

  4. Tmax

    Time frame: Approximately 18 months

    Time of highest observed plasma concentration of JAB-8263

  5. T1/2

    Time frame: Approximately 18 months

    Half life of JAB-8263

  6. Objective response rate ( ORR )

    Time frame: Approximately 18 months

    For solid tumor study part, ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

  7. Duration of response ( DOR )

    Time frame: Approximately 18 months

    For solid tumor study part, DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

  8. Duration of response ( DCR )

    Time frame: Approximately 18 months

    For solid tumor study part, DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).

  9. CR without minimal residual disease rate (CR MRD-)

    Time frame: Approximately 18 months

    hematology study part, CR MRD- is defined as proportion of participants with complete response without minimal residual disease.

  10. Overall response rate

    Time frame: Approximately 18 months

    For hematology study part, Overall response rate is defined as proportion of participants with complete response(CR or CRi), partial remission(PR) or morphologic leukemia-free state(MLFS).

  11. Event-free survival( EFS)

    Time frame: Approximately 18 months

    For hematology study part, EFS is defined for all patients with AML, measured from the date of entry into the study to the date of primary refractory disease, or relapse from CR, or Cri, or death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacobio Pharmaceuticals

CONTACT

[email protected]

86 10 56315466

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2020
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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