Status:
COMPLETED
A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China
Lead Sponsor:
Allist Pharmaceuticals, Inc.
Conditions:
Non-small Cell Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 approxim...
Eligibility Criteria
Inclusion
- 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 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 v1.1.
- Patients who have sufficient baseline organ function
Exclusion
- 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.
- 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-3312.
- 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.
- History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
- Subjects experiencing unresolved Grade \>1 toxicity before the start of treatment
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04121286
Start Date
July 14 2020
End Date
June 17 2022
Last Update
May 20 2025
Active Locations (5)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Peking Union Medical Collage Hospital
Beijing, China
4
Peking University Third Hospital
Beijing, China