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

May 20, 2026 updated by: Jacobio Pharmaceuticals Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

144

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Research Site
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Research Site
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Research Site
    • Henan
      • Zhengzhou, Henan, China, 451191
        • Recruiting
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Research Site
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Research Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Research Site
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Research Site
    • Florida
      • Lake Mary, Florida, United States, 32771
        • Terminated
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Terminated
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation phase
Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)
Drug: JAB-30355
Oral administration
Experimental: Dose expansion phase
Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
Drug: JAB-30355
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity (DLT)
Time Frame: Approximately one year
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Approximately one year
Number of participants with adverse events
Time Frame: Approximately three years
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
Approximately three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: Approximately three years
Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Approximately three years
Time to reach the observed maximum (peak) concentration (Tmax)
Time Frame: Approximately three years
Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Approximately three years
Terminal half-life (t1/2)
Time Frame: Approximately three years
Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Approximately three years
Objective response rate (ORR)
Time Frame: Approximately three years
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Approximately three years
Duration of response (DOR)
Time Frame: Approximately three years
DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.
Approximately three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAB-30355-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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