Description:
This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety,
tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in
adult patients with advanced solid.
Title
- Brief Title: A First in Human, Dose Escalation Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors
- Official Title: A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
JAB-3068-01
- NCT ID:
NCT03518554
Conditions
- Non-small Cell Lung Cancer
- Head and Neck Cancer
- Esophageal Cancer
- Other Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
JAB-3068 | | JAB-3068 (SHP2 inhibitor) |
Purpose
This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety,
tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in
adult patients with advanced solid.
Trial Arms
Name | Type | Description | Interventions |
---|
JAB-3068 (SHP2 inhibitor) | Experimental | Daily oral administration of JAB-3068 | |
Eligibility Criteria
Inclusion Criteria:
1. Written informed consent obtained prior to any study-related procedure being
performed;
2. Age 18 years or older;
3. Patients with histologically or cytologically confirmed, advanced solid tumors which
have progressed despite standard therapy or for whom no standard therapy exists;
4. Patients with life expectancy ≥3 months;
5. Patients must have at least one measurable lesion as defined by RECIST v1.1;
6. Eastern Cooperative Oncology Group performance score 0 or 1;
7. Patients who have sufficient baseline organ function.
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. 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 or 5 half-lives (whichever is shorter)
prior to the first dose of JAB-3068;
8. Use of an investigational drug during the past 30 days or 5 half-lives (whichever is
shorter) prior to the first dose of JAB-3068;
9. No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy
radiotherapy (except for palliative local radiotherapy), biological therapy or other
novel agent is to be permitted while the patient is receiving study medication.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with dose limiting toxicities |
Time Frame: | up to 28-day per cycle |
Safety Issue: | |
Description: | 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-3068. |
Secondary Outcome Measures
Measure: | Number of participants with adverse events |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | 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 |
Measure: | Area under the curve |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | Area under the plasma concentration time curve of JAB-3068 |
Measure: | Cmax |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | Highest observed plasma concentration of JAB-3068 |
Measure: | Tmax |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | Time of highest observed plasma concentration of JAB-3068 |
Measure: | T1/2 |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | Half life of JAB-3068 |
Measure: | Objective response rate |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | ORR is defined as the proportion of participants with complete response or partial response (CR+PR) |
Measure: | Duration of response |
Time Frame: | Approximately 2 years |
Safety Issue: | |
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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jacobio Pharmaceuticals Co., Ltd. |
Trial Keywords
- JAB-3068
- SHP2
- advanced solid tumor
- NSCLC
- ESCC
- HNSCC
- PTPN11
- EGFR
- Colorectal cancer
Last Updated
March 26, 2021