## Protocol Section
### Identification Module
**NCT ID:** NCT04587479

**Brief Title:** A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

**Official Title:** A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Subjects With Advanced Solid Tumors

#### Organization Study ID Info
**ID:** JAB-8263-1001
#### Organization
**Class:** INDUSTRY
**Full Name:** Jacobio Pharmaceuticals Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2023-04-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-03-14

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-11-23

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2020-10-14
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-09
**Study First Submit QC Date:** 2020-10-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jacobio Pharmaceuticals Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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.

**Detailed Description:** JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263

### Conditions Module

**Conditions:**

- Solid Tumors, Adult

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Monotherapy, dose escalation

**Intervention Names:**

- Drug: JAB-8263

**Label:** JAB-8263

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JAB-8263

**Description:** Variable dose, orally Q2D with 28 days each cycle

**Name:** JAB-8263

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Number of participants with dose limiting toxicities

**Time Frame:** Approximately 2.5 years

**Description:** 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)

**Measure:** Find Recommended Phase 2 Dose (RP2D) of JAB-8263

**Time Frame:** Approximately 2.5 years

#### Secondary Outcomes

**Description:** All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

**Measure:** Number of participants with adverse events

**Time Frame:** Approximately 2.5 years

**Description:** Area under the plasma concentration time curve of JAB-8263

**Measure:** Area under the curve

**Time Frame:** Approximately 2.5 years

**Description:** Highest observed plasma concentration of JAB-8263

**Measure:** Cmax

**Time Frame:** Approximately 2.5 years

**Description:** Time of highest observed plasma concentration of JAB-8263

**Measure:** Tmax

**Time Frame:** Approximately 2.5 years

**Description:** Half life of JAB-8263

**Measure:** T1/2

**Time Frame:** Approximately 2.5 years

**Description:** ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

**Measure:** Objective response rate ( ORR )

**Time Frame:** Approximately 2.5 years

**Description:** DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

**Measure:** Duration of response ( DOR )

**Time Frame:** Approximately 2.5 years

### Eligibility Module

**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 life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@jacobiopharma.com

**Name:** Jacobio Pharmaceuticals

**Phone:** 86 10 56315466

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Denver

**Contacts:**

***Contact 1:***

- **Name:** Gerald Falchook, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** SCRI HeatlthONE

**State:** Colorado

**Status:** RECRUITING

**Zip:** 80218

**Location 2:**

**City:** Lake City

**Contacts:**

***Contact 1:***

- **Name:** Shekeab Jauhari, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Florida Cancer Center, Lake Mary

**State:** Florida

**Status:** RECRUITING

**Zip:** 32025

**Location 3:**

**City:** Nashville

**Contacts:**

***Contact 1:***

- **Name:** James M Pauff, MD PhD

- **Role:** CONTACT

**Country:** United States

**Facility:** Tennessee Oncology Nashville

**State:** Tennessee

**Status:** RECRUITING

**Zip:** 37203

#### Overall Officials

**Official 1:**

**Affiliation:** Jacobio Pharmaceuticals

**Name:** Jacobio Pharmaceuticals

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
