RecruitingPhase 1Phase 2NCT04686682

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Enrollment

152 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

Ovarian Carcinoma NSCLC SCLC ESCC AML CRPC Malignant Tumor MF

Summary

This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new experimental drug called JAB-8263 in adults with advanced solid tumors or a blood cancer called AML (acute myeloid leukemia) that has stopped responding to standard treatments. The study is finding the right dose and checking safety. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor that progressed despite standard therapies, or there are no standard options for your cancer - You have relapsed or refractory AML - Your life expectancy is at least 3 months - You are in reasonably good health (ECOG 0–1) and your organs function adequately - Your solid tumor has at least one measurable lesion on scans **You may NOT be eligible if...** - Your performance status is too low (ECOG ≥ 2) - Your organ function is inadequate - Your life expectancy is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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