First-in-human use of JAB-8263 in adults with advanced solid and blood cancers
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
This trial will try JAB-8263, a BET inhibitor pill, in adults with advanced solid tumors or blood cancers that have progressed after standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT04686682 on ClinicalTrials.gov |
What this trial studies
This is an open-label phase 1/2a first-in-human study with two parallel parts: dose escalation and expansion for advanced solid tumors and a separate dose escalation and expansion for hematologic tumors. The study will enroll about 30 subjects in each part to identify the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose-limiting toxicities (DLTs). Investigators will also collect safety data, pharmacokinetics and pharmacodynamics, and preliminary antitumor activity signals. The single listed site for this protocol is in Tianjin, China, and dosing and follow-up visits will be conducted at the study center.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with ECOG 0–1 who have histologically confirmed advanced solid tumors (including NSCLC, SCLC, CRPC, ESCC, ovarian carcinoma) or refractory hematologic malignancies that progressed after or are intolerant of standard treatments, have measurable disease and adequate organ function.
Not a fit: Patients unlikely to benefit include those with poor performance status (ECOG ≥2), inadequate organ function, recent other primary cancers, known serious allergy to the drug or excipients, or who cannot travel to the Tianjin site.
Why it matters
Potential benefit: If successful, JAB-8263 could offer a new targeted treatment option that may shrink tumors or slow disease progression in patients whose cancers no longer respond to standard therapy.
How similar studies have performed: Other BET inhibitors have shown promising preclinical activity but early clinical trials have produced mixed responses with some signals of activity alongside notable toxicities such as thrombocytopenia, so clinical benefit remains uncertain.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jacobio Pharmaceuticals
- Email: clinicaltrials@jacobiopharma.com
- Phone: 86 10 56315466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.