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NCT06386146 | RECRUITING | Solid Tumors

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

Jacobio Pharmaceuticals Co., Ltd.

Brief Summary:

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

Condition or disease

Solid Tumors

Intervention/treatment

JAB-30355

JAB-30355

Phase

PHASE1

PHASE2

Detailed Description:

This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.

Study Type : INTERVENTIONAL
Estimated Enrollment : 144 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
Actual Study Start Date : 2024-07-24
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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.
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

Location Details

NCT06386146

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Research Site

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Research site

Lake Mary, Florida, United States, 32771

RECRUITING

United States, Missouri

Research site

Saint Louis, Missouri, United States, 63110

TERMINATED

United States, Ohio

Research site

Canton, Ohio, United States, 44718

RECRUITING

United States, Ohio

Research site

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Research site

Houston, Texas, United States, 77030

RECRUITING

China, Beijing

Research Site

Beijing, Beijing, China, 100000

RECRUITING

China, Beijing

Research Site

Beijing, Beijing, China, 100021

RECRUITING

China, Beijing

Research Site

Beijing, Beijing, China, 100142

NOT YET RECRUITING

China, Guangdong

Research Site

Guangzhou, Guangdong, China, 510000

NOT YET RECRUITING

China, Shandong

Research Site

Women, Shandong, China, 250117

RECRUITING

China, Shanghai

Research Site

Shanghai, Shanghai, China, 200032