CompletedPhase 1NCT03518554
Official study title

A First in Human, Dose Escalation Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJAB-3068

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 16, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Jacobio Pharmaceuticals Co., Ltd.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
Interventions being studied
Drug: JAB-3068
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HealthONE Clinic Services Oncology-HematologyDenver, Colorado
  • Florida Cancer SpecialistsSarasota, Florida
  • Sarah Cannon Research InstituteNashville, Tennessee
  • The University of Texas M. D. Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 16, 2024. Always confirm current availability with the study team.

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