A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

Phase 1

Recruiting

• Conditions: Colorectal Cancer; Non-small Cell Lung Cancer; Esophageal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Other Solid Tumors; Pancreatic Ductal Carcinoma
• Interventions: Drug: JAB-3312

• Registration Number: NCT04121286
• Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Brief Summary

This is a Phase 1, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2020-06-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JAB-3312	JAB-3312	JAB-3312 will be administered orally once daily in 21 days treatment cycles.

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities	Approximately 2 years	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.
Find Recommended Phase 2 Dose (RP2D) of JAB-3312	Approximately 2 years	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)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Approximately 2 years	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
T1/2	Approximately 2 years	Half life of JAB-3312
Duration of response ( DOR )	Approximately 2 years	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.
Cmax	Approximately 2 years	Highest observed plasma concentration of JAB-3312
Area under the curve	Approximately 2 years	Area under the plasma concentration time curve of JAB-3312
Objective response rate ( ORR )	Approximately 2 years	ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Tmax	Time of highest observed plasma concentration of JAB-3312	Time of highest observed plasma concentration of JAB-3312

Trial Locations

Locations (5)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Henan Provovential Cancer Hospital; 🇨🇳 Henan, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Peking Union Medical Collage Hospital; 🇨🇳 Beijing, China