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NCT Number: NCT05490472

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

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Key information

Conditions

Solid Tumors ARID1A Gene Mutation Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic ER+ Breast Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer, SCLC Small Cell Lung Carcinoma Thoracic Neoplasms Triple Negative Breast Cancer, TNBC Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must be able to provide an archived tumor sample
  • Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
  • Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
  • Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Must have adequate organ functions
  • Must be able to swallow and retain orally administered medication

Exclusion criteria

  • Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 7 days
  • Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
  • Any severe and/or uncontrolled medical conditions
  • left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
  • QT interval using Fridericia's formula (QTcF) interval >470 msec
  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
  • Clinically significant eye disorders

Treatment and study plan

JAB-2485 (Aurora A inhibitor)

Drug

Administered orally

Primary outcomes

  1. Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)

    Time frame: First 21 days of Cycle 1

    A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period).

  2. Dose Escalation phase: Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

    Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0

  3. Dose Expansion phase: Objective Response Rate (ORR)

    Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)

    ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1

  4. Dose Expansion phase: Duration of Response (DOR)

    Time frame: Up to 3 years

    DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Dose Escalation phase: Objective Response Rate (ORR)

    Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)

    ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1

  2. Dose Escalation and Dose Expansion phase: Time to response (TTR)

    Time frame: Up to 3 years

    TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1

  3. Dose Escalation phase: Duration of Response (DOR)

    Time frame: Up to 3 years

    DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first

  4. Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)

  5. Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including time to peak plasma concentration (tmax)

  6. Dose Escalation and Dose Expansion phase: Ctrough

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including pre-dose through concentration (Ctrough)

  7. Dose Escalation and Dose Expansion phase: Area under the curve (AUC)

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including area under the plasma concentration versus time curve (AUC)

  8. Dose Escalation and Dose Expansion phase: half-life (t½)

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)

  9. Dose Escalation and Dose Expansion phase: total body clearance

    Time frame: Up to 3 years

    Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance

  10. Dose Expansion phase: Progression Free Survival (PFS)

    Time frame: Up to 3 years

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST v1.1 or death which occurs first.

  11. Dose Expansion Phase 2a: Overall Survival (OS)

    Time frame: Up to 3 years

    OS is defined as the length of time between the date of first treatment to the date of death

  12. Dose Expansion phase: Disease Control Rate (DCR)

    Time frame: Up to 3 years

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1

  13. Dose Expansion phase: Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

    Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0

Study contacts

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

Jacobio Pharmaceuticals

CONTACT

[email protected]

(781) 918-6670

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2022
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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