JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumors

In brief

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

Key facts

Study ID

NCT06386146

Run by

Jacobio Pharmaceuticals Co., Ltd.

People needed

144

Starts

2024-07-24

Expected to finish

2027-07-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent.
• Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
• ECOG performance status score of 0 or 1.
• Has been treated with at least one line of systemic therapy for that tumor type and stage.
• Have documentation of confirmed TP53 Y220C mutation.
• At least 1 measurable lesion per RECIST v1.1.
• Adequate hematological, renal and hepatic function and appropriate coagulation condition.
• Able to swallow and retain orally administered medication.

You may not qualify if…

• Active brain or spinal metastases or primary CNS tumor.
• Active infection requiring systemic treatment within 7 days.
• Active HBV or HCV.
• Any severe and/or uncontrolled medical conditions.
• LVEF ≤50% assessed by ECHO or MUGA.
• QTcF > 470 msec.

Where it is running

• Research Site — Shanghai, Shanghai Municipality, China (enrolling)
• Research Site — Jinan, Shandong, China (enrolling)
• Research Site — Denver, Colorado, United States (enrolling)
• Research site — St Louis, Missouri, United States (enrolling)
• Research site — Cleveland, Ohio, United States (enrolling)
• Research Site — Nashville, Tennessee, United States (enrolling)
• Research site — Houston, Texas, United States (enrolling)
• Research Site — Beijing, Beijing Municipality, China (enrolling)
• Research Site — Beijing, Beijing Municipality, China (enrolling)
• Research Site — Beijing, Beijing Municipality, China (enrolling)
• Research Site — Guangzhou, Guangdong, China (enrolling)
• Research Site — Zhengzhou, Henan, China (enrolling)
• Research Site — Shenyang, Liaoning, China (enrolling)
• Research site — Lake Mary, Florida, United States
• Research site — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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