A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04045496 |
Recruitment Status :
Recruiting
First Posted : August 5, 2019
Last Update Posted : March 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: JAB-3312 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 26, 2019 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2024 |

Arm | Intervention/treatment |
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Experimental: JAB-3312
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
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Drug: JAB-3312
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules. |
- 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)
- Number of participants with adverse events [ Time Frame: Approximately 2 years ]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 [ Time Frame: Approximately 2 years ]Area under the plasma concentration time curve of JAB-3312
- Cmax [ Time Frame: Approximately 2 years ]Highest observed plasma concentration of JAB-3312
- Tmax [ Time Frame: Approximately 2 years ]Time of highest observed plasma concentration of JAB-3312
- T1/2 [ Time Frame: Approximately 2 years ]Half life of JAB-3312
- Objective response rate ( ORR ) [ Time Frame: Approximately 2 years ]ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
- Duration of response ( DOR ) [ Time Frame: Approximately 2 years ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045496
Contact: Jacobio Pharmaceuticals | 86 10 56315466 | clinicaltrials@jacobiopharma.com |
United States, Colorado | |
HealthONE Clinic Services Oncology-Hematology | Recruiting |
Denver, Colorado, United States, 80202 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
The University of Texas M. D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Washington University School of Medicine | Recruiting |
Seattle, Washington, United States, 63110 |
Study Director: | Jacobio Pharmaceuticals | Jacobio Pharmaceuticals |
Responsible Party: | Jacobio Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04045496 |
Other Study ID Numbers: |
JAB-3312-1001 |
First Posted: | August 5, 2019 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Src homology phosphatase 2 (SHP2) PTPN11 Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase epidermal growth factor receptor (EGFR) |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Esophageal Squamous Cell Carcinoma Carcinoma, Ductal Carcinoma, Pancreatic Ductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Neoplasms, Squamous Cell Head and Neck Neoplasms Esophageal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |