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A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

Primary Purpose

Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

JAB-3312

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)

Eligibility Criteria

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

Inclusion Criteria:

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 or for which no standard therapy exists.
Subjects with life expectancy ≥3 months.
Patients must have at least one measurable lesion as defined by RECIST v1.1.
Patients who have sufficient baseline organ function

Exclusion Criteria:

Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
History or evidence of active infections (Grade ≥2).
History or evidence of significant inflammatory or vascular eye disorder.
History of an allogeneic bone marrow or solid organ transplant.
Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
Subjects experiencing unresolved Grade >1 toxicity before the start of treatment

Sites / Locations

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Peking Union Medical Collage Hospital
Peking University Third Hospital
Henan Provovential Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JAB-3312

Arm Description

JAB-3312 will be administered orally once daily in 21 days treatment cycles.

Outcomes

Primary Outcome Measures

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-3312.

Find Recommended Phase 2 Dose (RP2D) of JAB-3312

Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)

Secondary Outcome Measures

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

Area under the curve

Area under the plasma concentration time curve of JAB-3312

Cmax

Highest observed plasma concentration of JAB-3312

Tmax

Time of highest observed plasma concentration of JAB-3312

T1/2

Half life of JAB-3312

Objective response rate ( ORR )

ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

Duration of response ( DOR )

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.

Full Information

NCT ID

NCT04121286

First Posted

September 29, 2019

Last Updated

February 16, 2023

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04121286

Brief Title

A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

Official Title

A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 10, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a Phase 1, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer, Other Solid Tumors

Keywords

Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Proposed dose Cohorts Cohort A：1mg Cohort B：2mg Cohort C：4mg Cohort D: 6mg Cohort E：8mg

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

JAB-3312

Arm Type

Experimental

Arm Description

JAB-3312 will be administered orally once daily in 21 days treatment cycles.

Intervention Type

Drug

Intervention Name(s)

JAB-3312

Intervention Description

JAB-3312 will be supplied as 0.25 mg, 1.0 mg and 4.0 mg capsules.

Primary Outcome Measure Information:

Title

Number of participants with dose limiting toxicities

Description

Time Frame

Approximately 2 years

Title

Find Recommended Phase 2 Dose (RP2D) of JAB-3312

Description

Time Frame

Approximately 2 years

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Time Frame

Approximately 2 years

Title

Area under the curve

Description

Area under the plasma concentration time curve of JAB-3312

Time Frame

Approximately 2 years

Title

Cmax

Description

Highest observed plasma concentration of JAB-3312

Time Frame

Approximately 2 years

Title

Tmax

Description

Time of highest observed plasma concentration of JAB-3312

Time Frame

Time of highest observed plasma concentration of JAB-3312

Title

T1/2

Description

Half life of JAB-3312

Time Frame

Approximately 2 years

Title

Objective response rate ( ORR )

Description

ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

Time Frame

Approximately 2 years

Title

Duration of response ( DOR )

Description

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.

Time Frame

Approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 or for which no standard therapy exists. Subjects with life expectancy ≥3 months. Patients must have at least one measurable lesion as defined by RECIST v1.1. Patients who have sufficient baseline organ function Exclusion Criteria: Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent). Known malignant central nervous system disease other than neurologically stable, treated brain metastases. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV). History or evidence of active infections (Grade ≥2). History or evidence of significant inflammatory or vascular eye disorder. History of an allogeneic bone marrow or solid organ transplant. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuankai Shi, MD

Phone

86 010 87788293

syuankaipumc@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuankai Shi, MD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianyang Liang, MD

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Shen, MD

Facility Name

Peking Union Medical Collage Hospital

City

Beijing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mengzhao Wang

Facility Name

Peking University Third Hospital

City

Beijing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baoshan Cao

Facility Name

Henan Provovential Cancer Hospital

City

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suxia Luo

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

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