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
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Number of participants with dose limiting toxicities
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
- •Subjects with life expectancy ≥3 months.
- •Patients must have at least one measurable lesion as defined by RECIST v1.
- •Patients who have sufficient baseline organ function.
Exclusion Criteria
- •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).
- •Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
- •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.
- •8\. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- •History or evidence of active infections (Grade ≥2).
- •History or evidence of significant inflammatory or vascular eye disorder.
- •History of an allogeneic bone marrow or solid organ transplant.
- •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-
- •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-
- •History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
Arms & Interventions
JAB-3312
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
Intervention: JAB-3312 (Drug)
Outcomes
Primary Outcomes
Number of participants with dose limiting toxicities
Time Frame: 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
Time Frame: 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 Outcomes
- T1/2(Approximately 2 years)
- Number of participants with adverse events(Approximately 2 years)
- Tmax(Approximately 2 years)
- Area under the curve(Approximately 2 years)
- Cmax(Approximately 2 years)
- Duration of response ( DOR )(Approximately 2 years)
- Objective response rate ( ORR )(Approximately 2 years)