NCT04686682 A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
| NCT ID | NCT04686682 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2021-05-07 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 152 participants in total. It began in 2021-05-07 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.
Eligibility Criteria
Inclusion Criteria: * Subjects must meet all the following criteria in order to be included in the research study: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists. 4. Subjects with recurrent/refractory AML according to WHO 2016 5. Subjects with life expectancy ≥3 months. 6. Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1. 7. Patients who have sufficient baseline organ function. Exclusion Criteria: 1. History (≤3 years) of cancer that is histologically distinct from the cancer under study. 2. Known serious allergy to investigational drug or excipients 3. Active brain or spinal metastases 4. History of pericarditis or Grade ≥2 pericardial effusion 5. History of interstitial lung disease. 6. History of Grade ≥2 active infections within 2 weeks 7. Known human immunodeficiency virus (HIV) infection 8. Seropositive for hepatitis B virus (HBV) 9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable. 10. Any severe and/or uncontrolled medical conditions 11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident 12. Impaired cardiac function or clinically significant cardiac diseases 13. QTcF \>470 msec at screening 14. History of medically significant thromboembolic events or bleeding diathesis 15. Unresolved Grade \>1 toxicity 16. History of malignant biliary obstruction 17. Pregnant or breast-feeding
Contact & Investigator
Jacobio Pharmaceuticals
STUDY DIRECTOR
Jacobio Pharmaceuticals
Frequently Asked Questions
Who can join the NCT04686682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04686682 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04686682 currently recruiting?
Yes, NCT04686682 is actively recruiting participants. Contact the research team at clinicaltrials@jacobiopharma.com for enrollment information.
Where is the NCT04686682 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT04686682 clinical trial?
NCT04686682 is sponsored by Jacobio Pharmaceuticals Co., Ltd.. The principal investigator is Jacobio Pharmaceuticals at Jacobio Pharmaceuticals. The trial plans to enroll 152 participants.