Non-small Cell Lung CancerPhase 1NCT04045496
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing JAB-3312 in people with Non-small Cell Lung Cancer and Colorectal Cancer, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.
Trial summary
This is a Phase 1, first-in-human, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma
- What is being tested?
- JAB-3312
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Sep 2019to 16 Dec 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
- 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.
Who cannot join
- 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.
- 8. 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.
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- 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.
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
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Washington University School of Medicine
Seattle, Washington, 63110
About this study
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
This is a Phase 1, first-in-human, 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.
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer
- Being tested
- JAB-3312
- Keywords
- Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Pancreatic Ductal, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Noonan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-3312Drug
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| JAB-3312 | Experimental | JAB-3312 will be administered orally once daily in 21 days treatment cycles. Receives: Drug: JAB-3312 |
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-3312.
Measured: Approximately 2 years
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)
Measured: Approximately 2 years
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-3312
Measured: Approximately 2 years
Cmax
Highest observed plasma concentration of JAB-3312
Measured: Approximately 2 years
Tmax
Time of highest observed plasma concentration of JAB-3312
Measured: Approximately 2 years
T1/2
Half life of JAB-3312
Measured: Approximately 2 years
Objective response rate ( ORR )
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Approximately 2 years
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.
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 posted5 Aug 2019
- Study start26 Sep 2019
- Primary completion16 Dec 2022
- Study completion16 Dec 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045496
- Sponsor's protocol ID
- JAB-3312-1001
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2019
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04045496
- Acronym / sponsor ID
- JAB-3312-1001
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer
- Keywords
- Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 5 Aug 2019 (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, first-in-human, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAB-3312 | Experimental | Drug: JAB-3312JAB-3312 will be administered orally once daily in 21 days treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- History or evidence of active infections (Grade ≥2).
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-3312JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules. | Drug | JAB-3312 |
Primary outcome
Number of participants with dose limiting toxicities
Time frame: Approximately 2 years
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
Time frame: Approximately 2 years
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)
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 ( ORR )
Time frame: Approximately 2 years
Duration of response ( DOR )
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 29 Dec 2025.
- Individual participant dataSharing planned: No
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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
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-3312 in people with Non-small Cell Lung Cancer and Colorectal 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 6 inclusion and 11 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 29 Dec 2025. 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: Approximately 2 years). The study lists 2 primary outcomes in all. 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 29 Dec 2025.