A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

NCT04587479 | Completed Phase 1 FDA Drug

• 1 other identifier: JAB-8263-1001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.

Conditions

Solid Tumors, Adult

Keywords

BET inhibitor; Bromodomain and Extra-terminal

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities

  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-8263

  Approximately 2.5 years

• Find Recommended Phase 2 Dose (RP2D) of JAB-8263

  Measurements of MTD (i.e. the highest dose of JAB-8263 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)

  Approximately 2.5 years

Secondary Outcomes (7)

• Number of participants with adverse events

  Approximately 2.5 years

• Area under the curve

  Approximately 2.5 years

• Cmax

  Approximately 2.5 years

• Tmax

  Approximately 2.5 years

• T1/2

  Approximately 2.5 years

Study Arms (1)

JAB-8263

EXPERIMENTAL

Monotherapy, dose escalation

Drug: JAB-8263

Interventions

JAB-8263 DRUG

Variable dose, orally Q2D with 28 days each cycle

JAB-8263

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• History (≤3 years) of cancer that is histologically distinct from the cancer under study.
• Known serious allergy to investigational drug or excipients
• Active brain or spinal metastases
• 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
• QTcF \>470 msec at screening
• History of medically significant thromboembolic events or bleeding diathesis
• Unresolved Grade \>1 toxicity

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (3)

SCRI HeatlthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Center, Lake Mary

Lake City, Florida, 32025, United States

Location

Tennessee Oncology Nashville

Nashville, Tennessee, 37203, United States

Location

Study Officials

• Jacobio Pharmaceuticals

  Jacobio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 14, 2020
• Study Start: November 23, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)