[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

86 10 56315466

Email address

clinicaltrials@jacobiopharma.com

Condition

Esophageal Cancer,Head and Neck Cancer,Non-small Cell Lung Cancer,Other Metastatic Solid Tumors

Treatment type

Interventional

Investigational product

JAB-3068

Phase

Phase 1

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

ClinicalTrials.gov identifier

NCT03518554

Study number

JAB-3068-01

Understanding clinical trials

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About the study

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Written informed consent obtained prior to any study-related procedure being performed;
  2. Age 18 years or older;
  3. Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
  4. Patients with life expectancy ≥3 months;
  5. Patients must have at least one measurable lesion as defined by RECIST v1.1;
  6. Eastern Cooperative Oncology Group performance score 0 or 1;
  7. Patients who have sufficient baseline organ function.
Exclusion criteria

  1. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
  2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
  3. Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
  4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  5. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
  6. Patients who have impaired cardiac function or clinically significant cardiac diseases;
  7. Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
  8. Use of an investigational drug during the past 30 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
  9. No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is to be permitted while the patient is receiving study medication.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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