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NCT Number: NCT06386146

JAB-30355 in 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.

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Key information

Conditions

Solid Tumors Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JAB-30355

Drug

Oral administration

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: Approximately one year

    Number and proportion of participants who experience at least one dose limiting toxicity (DLT)

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacobio Pharmaceuticals

CONTACT

[email protected]

781-918-6670

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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