Non-small Cell Lung CancerPhase 1NCT03518554
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing JAB-3068 in people with Non-small Cell Lung Cancer and Head and Neck Cancer, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer
- What is being tested?
- JAB-3068
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Apr 2018to 3 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-related procedure being performed;
- Age 18 years or older;
- Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
- Patients with life expectancy ≥3 months;
- Patients must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group performance score 0 or 1;
- Patients who have sufficient baseline organ function.
Who cannot join
- Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
- Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- 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
- Patients who have impaired cardiac function or clinically significant cardiac diseases;
Show all 9Show fewer
- Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
- 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;
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
HealthONE Clinic Services Oncology-Hematology
Denver, Colorado, 80202
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Florida Cancer Specialists
Sarasota, Florida, 37203
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors
- Being tested
- JAB-3068
- Keywords
- JAB-3068, SHP2, advanced solid tumor, NSCLC, ESCC, HNSCC, PTPN11, EGFR, Colorectal cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Esophageal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Noonan Syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-3068Drug
JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.
| Study group | Role | What they receive |
|---|---|---|
| JAB-3068 (SHP2 inhibitor) | Experimental | Daily oral administration of JAB-3068 Receives: Drug: JAB-3068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-3068.
Measured: up to 28-day per cycle
Secondary outcomes (7)
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
Measured: Approximately 2 years
Area under the curve
Area under the plasma concentration time curve of JAB-3068
Measured: Approximately 2 years
Cmax
Highest observed plasma concentration of JAB-3068
Measured: Approximately 2 years
Tmax
Time of highest observed plasma concentration of JAB-3068
Measured: Approximately 2 years
T1/2
Half life of JAB-3068
Measured: Approximately 2 years
Objective response rate
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Approximately 2 years
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.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start23 Apr 2018
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacobio Pharmaceuticals, Study director, Jacobio Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518554
- Sponsor's protocol ID
- JAB-3068-01
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2018
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03518554
- Acronym / sponsor ID
- JAB-3068-01
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors
- Keywords
- JAB-3068, SHP2, advanced solid tumor, NSCLC, ESCC, HNSCC, PTPN11, EGFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAB-3068 (SHP2 inhibitor) | Experimental | Drug: JAB-3068Daily oral administration of JAB-3068 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained prior to any study-related procedure being performed;
- Age 18 years or older;
- Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
- Patients with life expectancy ≥3 months;
- Patients must have at least one measurable lesion as defined by RECIST v1.1;
Key exclusion criteria (9 listed)
- Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
- Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-3068JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing. | Drug | JAB-3068 (SHP2 inhibitor) |
Primary outcome
Number of participants with dose limiting toxicities
Time frame: up to 28-day per cycle
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.
7 secondary outcomes
Number of participants with adverse events
Time frame: Approximately 2 years
Area under the curve
Time frame: Approximately 2 years
Cmax
Time frame: Approximately 2 years
Tmax
Time frame: Approximately 2 years
T1/2
Time frame: Approximately 2 years
Objective response rate
Time frame: Approximately 2 years
Duration of response
Time frame: Approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobio Pharmaceuticals study director
Jacobio Pharmaceuticals Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JAB-3068 in people with Non-small Cell Lung Cancer and Head and Neck Cancer, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (time frame: up to 28-day per cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.