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JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Primary Purpose

Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JAB-2485 (Aurora A inhibitor)
JAB-2485 (Aurora A inhibitor)
Sponsored by
Jacobio Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mary Crowley Cancer ResearchRecruiting
  • University of Utah Huntsman Cancer InstituteRecruiting
  • Research site02
  • Research site01
  • Research site03

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JAB-2485 monotherapy, Phase 1, Dose Escalation

JAB-2485 monotherapy, Phase 2a, Dose Expansion

Arm Description

Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.

JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.

Outcomes

Primary Outcome Measures

Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
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).
Dose Escalation phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Dose Expansion phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1
Dose Expansion phase: Duration of Response (DOR)
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 Outcome Measures

Dose Escalation phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1
Dose Escalation and Dose Expansion phase: Time to response (TTR)
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
Dose Escalation phase: Duration of Response (DOR)
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
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
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)
Dose Escalation and Dose Expansion phase: Ctrough
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)
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
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)
Dose Escalation and Dose Expansion phase: half-life (t½)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)
Dose Escalation and Dose Expansion phase: total body clearance
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance
Dose Expansion phase: Progression Free Survival (PFS)
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.
Dose Expansion Phase 2a: Overall Survival (OS)
OS is defined as the length of time between the date of first treatment to the date of death
Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Dose Expansion phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0

Full Information

First Posted
July 25, 2022
Last Updated
January 4, 2023
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05490472
Brief Title
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacobio Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JAB-2485 monotherapy, Phase 1, Dose Escalation
Arm Type
Experimental
Arm Description
Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.
Arm Title
JAB-2485 monotherapy, Phase 2a, Dose Expansion
Arm Type
Experimental
Arm Description
JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
Intervention Type
Drug
Intervention Name(s)
JAB-2485 (Aurora A inhibitor)
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
JAB-2485 (Aurora A inhibitor)
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Description
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).
Time Frame
First 21 days of Cycle 1
Title
Dose Escalation phase: Number of participants with adverse events (AEs)
Description
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Time Frame
Up to 3 years
Title
Dose Expansion phase: Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1
Time Frame
Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Title
Dose Expansion phase: Duration of Response (DOR)
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Dose Escalation phase: Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1
Time Frame
Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Title
Dose Escalation and Dose Expansion phase: Time to response (TTR)
Description
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
Time Frame
Up to 3 years
Title
Dose Escalation phase: Duration of Response (DOR)
Description
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
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Description
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
Description
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)
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Ctrough
Description
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)
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
Description
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)
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: half-life (t½)
Description
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: total body clearance
Description
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance
Time Frame
Up to 3 years
Title
Dose Expansion phase: Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 3 years
Title
Dose Expansion Phase 2a: Overall Survival (OS)
Description
OS is defined as the length of time between the date of first treatment to the date of death
Time Frame
Up to 3 years
Title
Dose Expansion phase: Disease Control Rate (DCR)
Description
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Time Frame
Up to 3 years
Title
Dose Expansion phase: Number of participants with adverse events (AEs)
Description
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobio Pharmaceuticals
Phone
(781) 918-6670
Email
clinicaltrials@jacobiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwen He
Email
Zhiwen.he@jacobiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobio Pharmaceuticals
Organizational Affiliation
Jacobio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Research site02
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site01
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site03
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

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