NCT04686682RecruitingPhase 1/2
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 23 Dec 2020
- Start date
- 7 May 2021
- Primary completion date
- Jan 2028
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Diseases
- Ovarian cancer
- NCT number
- NCT04686682
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 152
- From 7 May 2021 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known serious allergy to investigational drug or excipients
Other illness
- History of pericarditis or Grade ≥2 pericardial effusion
- History of interstitial lung disease.
- History of Grade ≥2 active infections within 2 weeks
- Known human immunodeficiency virus (HIV) infection
- Seropositive for hepatitis B virus (HBV)
- Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
- Any severe and/or uncontrolled medical conditions
- History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
- Impaired cardiac function or clinically significant cardiac diseases
- History of medically significant thromboembolic events or bleeding diathesis
- History of malignant biliary obstruction
Age
- History (≤3 years) of cancer that is histologically distinct from the cancer under study.
Other
- Active brain or spinal metastases
- QTcF \>470 msec at screening
- Unresolved Grade \>1 toxicity
- Pregnant or breast-feeding
Who the study is looking for
- Subjects must meet all the following criteria in order to be included in the research study:
- 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(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
- Subjects with recurrent/refractory AML according to WHO 2016
- Subjects with life expectancy ≥3 months.
- Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
- Patients who have sufficient baseline organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.