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

NCT ID: NCT06386146

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2027-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation phase

Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)

Group Type EXPERIMENTAL

JAB-30355

Intervention Type DRUG

Oral administration

Dose expansion phase

Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.

Group Type EXPERIMENTAL

JAB-30355

Intervention Type DRUG

Oral administration

Interventions

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JAB-30355

Oral administration

Intervention Type DRUG

JAB-30355

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Research Site

Denver, Colorado, United States

Site Status RECRUITING

Research site

Lake Mary, Florida, United States

Site Status RECRUITING

Research site

St Louis, Missouri, United States

Site Status RECRUITING

Research site

Canton, Ohio, United States

Site Status TERMINATED

Research site

Cleveland, Ohio, United States

Site Status RECRUITING

Research Site

Nashville, Tennessee, United States

Site Status RECRUITING

Research site

Houston, Texas, United States

Site Status RECRUITING

Research Site

Beijing, Beijing Municipality, China

Site Status RECRUITING

Research Site

Beijing, Beijing Municipality, China

Site Status RECRUITING

Research Site

Beijing, Beijing Municipality, China

Site Status RECRUITING

Research Site

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Research Site

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Countries

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United States China

Central Contacts

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Jacobio Pharmaceuticals

Role: CONTACT

781-918-6670

Other Identifiers

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JAB-30355-1001

Identifier Type: -

Identifier Source: org_study_id

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