First-in-human use of JAB-8263 in adults with advanced solid and blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Jacobio Pharmaceuticals
• Email: clinicaltrials@jacobiopharma.com
• Phone: 86 10 56315466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.