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

Last updated: April 16, 2025
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Solid Tumors

Neoplasms

Treatment

JAB-30355

Clinical Study ID

NCT06386146
JAB-30355-1001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent.

  • Participant must be ≥18 years of age at the time of signing the Informed ConsentForm (ICF).

  • ECOG performance status score of 0 or 1.

  • Has been treated with at least one line of systemic therapy for that tumor type andstage.

  • Have documentation of confirmed TP53 Y220C mutation.

  • At least 1 measurable lesion per RECIST v1.1.

  • Adequate hematological, renal and hepatic function and appropriate coagulationcondition.

  • Able to swallow and retain orally administered medication.

Exclusion

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 Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: JAB-30355
Phase: 1/2
Study Start date:
July 24, 2024
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Research Site

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Research Site

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Research Site

    Jinan, Shandong 250117
    China

    Site Not Available

  • Research Site

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Research Site

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Research site

    Lake Mary, Florida 32771
    United States

    Active - Recruiting

  • Research site

    Rochester, Minnesota 55906
    United States

    Site Not Available

  • Research site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research site

    Canton, Ohio 44718
    United States

    Terminated

  • Research site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research site

    Houston, Texas 77030
    United States

    Active - Recruiting

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