A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

Breast Cancer Clinical Trial

Official title:

A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045496
• Other study ID #: JAB-3312-1001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 26, 2019
• Est. completion date: March 2024

Study information

• Verified date: March 2022
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86 10 56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 or for which no standard therapy 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. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).

2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases.

3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.

4. 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).

5. History or evidence of active infections (Grade =2).

6. History or evidence of significant inflammatory or vascular eye disorder.

7. History of an allogeneic bone marrow or solid organ transplant.

8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug =28 days prior to the first dose of JAB-3312.

9. History of radiation therapy =28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.

10. History of transfusion of whole blood, red blood cell or platelet packets =2 weeks before the start of treatment.

11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Pancreatic Ductal
• Carcinoma, Squamous Cell
• Colorectal Cancer
• Esophageal Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma
• Non-small Cell Lung Cancer
• Other Solid Tumors
• Pancreatic Ductal Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• JAB-3312
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.

Locations

Country	Name	City	State
United States	HealthONE Clinic Services Oncology-Hematology	Denver	Colorado
United States	The University of Texas M. D. Anderson Cancer Center	Houston	Texas
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Washington University School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-3312.	Approximately 2 years
Primary	Find Recommended Phase 2 Dose (RP2D) of JAB-3312	Measurements of MTD (i.e. the highest dose of JAB-3312 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 years
Secondary	Number of participants with adverse events	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	Approximately 2 years
Secondary	Area under the curve	Area under the plasma concentration time curve of JAB-3312	Approximately 2 years
Secondary	Cmax	Highest observed plasma concentration of JAB-3312	Approximately 2 years
Secondary	Tmax	Time of highest observed plasma concentration of JAB-3312	Approximately 2 years
Secondary	T1/2	Half life of JAB-3312	Approximately 2 years
Secondary	Objective response rate ( ORR )	ORR is defined as the proportion of participants with complete response or partial response (CR+PR)	Approximately 2 years
Secondary	Duration of response ( DOR )	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.	Approximately 2 years