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CompletedNCT03565003Updated Sep 25, 2024

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China

A Phase 1/2 interventional study of JAB-3068 in Non-small Cell Lung Cancer, Head and Neck Cancer and Esophageal Cancer, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Completed at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
126
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.

Read the detailed description

Dose escalation study phase is designed to determine the maximum tolerated dose (MTD) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of JAB-3068. Other dose regimens may be explored based on the analysis of emerging PK and safety data. at this study phase, JAB-3068 dministered orally once daily (QD) or twice daily (BID) or once every other day (QOD) in 28-day treatment cycles to adult patients with advanced solid tumors,

Dose expansion study phase is designed to evaluate the antitumor activity(ORR and DOR) of JAB-3068 in patients with NSCLC, ESCC and HNSCC.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Head and Neck Cancer
  • Esophageal Cancer
  • Other Metastatic Solid Tumors

Keywords

  • JAB-3068
  • SHP2
  • PTPN11
  • ESCC
  • NSCLC
  • HNSCC
  • Colorectal cancer (CRC)
  • EGFR
03

In context

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent obtained prior to any study-related procedure being performed;
  2. Age 18 years or older;
  3. Dose escalation(phase I): Patients with histologically or cytologically confirmed, advanced solid tumors (including lymphoma) which have progressed from standard therapy or for whom no standard therapy exists; Dose expansion(phase IIa ): Patients with histologically or cytologically confirmed, advanced NSCLC, ESCC, HNSCC which have progressed from standard therapy;
  4. Patients with life expectancy ≥3 months;
  5. Dose expansion(phase IIa ): patients have available archival tissue can be provided or willing to perform biopsy to provide fresh tumor tissue.
  6. Patients with other solid tumors must have at least one measurable lesion as defined by RECIST v1.1;Patients with Lymphomas must have at least one measurable lesion as defined by IWG 2007 criteria;
  7. Eastern Cooperative Oncology Group performance score 0 or 1;
  8. Patients who have sufficient baseline organ function.

Exclusion criteria

Exclusion Criteria:

  1. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
  2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
  3. Lymphoma with brain metastasis; Other solid tumors:Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
  4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  5. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
  6. Patients who have impaired cardiac function or clinically significant cardiac diseases
  7. Use of anti-cancer treatment drug ≤21 days prior to the first dose of JAB-3068.
  8. Use of an investigational drug during the past 30 days prior to the first dose of JAB-3068.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    JAB-3068 (SHP2 inhibitor)

    JAB-3068 will be administered orally in the morning following a fast of approximately 6 hours before on PK collection. Patients will continue to fast for approximately 2 hours after the administration of JAB-3068. On non-PK days patients will fast approximately 2 hours before JAB-3068 and continue to fast for approximately 2 hours afterwards.

    Drug: JAB-3068

Interventions

  • DrugJAB-3068

    25 mg,100 mg

06

What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Number of participants with 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-3068.

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

  2. Objective response rate

    ORR is defined as the proportion of participants with complete response or partial. the ORR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

    Time frame: Approximately 2 years

  3. Duration of response

    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. The DOR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

    Time frame: Approximately 2 years

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 2 years

  2. Area under the curve

    Area under the plasma concentration time curve of JAB-3068

    Time frame: Approximately 2 years

  3. Cmax

    Highest observed plasma concentration of JAB-3068

    Time frame: Approximately 2 years

  4. Tmax

    Time of highest observed plasma concentration of JAB-3068

    Time frame: Approximately 2 years

  5. T1/2

    Half life of JAB-3068

    Time frame: Approximately 2 years

  6. Objective response rate

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

    Time frame: Approximately 2 years

  7. Duration of response

    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 in dose escalation.

    Time frame: Approximately 2 years

07

Study locations

4 sites
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing 100021, China
  • Peking Union Medical College Hospital
    Beijing, Beijing 100032, China
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
  • Chinese PLA Central Hospital
    Beijing, Beijing 100853, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03565003
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Nov 20, 2018
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Last update
Sep 25, 2024

Study contacts

Yuankai Shi, MD
study chair · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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