NCT06386146

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_1

Timeline
14mo left

Started Jul 2024

Typical duration for phase_1

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jul 2024Jul 2027

First Submitted

Initial submission to the registry

April 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 24, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

April 23, 2024

Last Update Submit

January 20, 2026

Conditions

Solid Tumors

Keywords

TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicity (DLT)

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

    Approximately one year

  • Number of participants with adverse events

    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 Outcomes (5)

  • Peak Plasma Concentration (Cmax)

    Approximately three years

  • Time to reach the observed maximum (peak) concentration (Tmax)

    Approximately three years

  • Terminal half-life (t1/2)

    Approximately three years

  • Objective response rate (ORR)

    Approximately three years

  • Duration of response (DOR)

    Approximately three years

Study Arms (2)

Dose escalation phase

EXPERIMENTAL

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

Drug: JAB-30355

Dose expansion phase

EXPERIMENTAL

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

Drug: JAB-30355

Interventions

JAB-30355DRUG

Oral administration

Dose escalation phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Denver, Colorado, 80218, United States

RECRUITING

Research site

Lake Mary, Florida, 32771, United States

RECRUITING

Research site

St Louis, Missouri, 63110, United States

RECRUITING

Research site

Canton, Ohio, 44718, United States

TERMINATED

Research site

Cleveland, Ohio, 44195, United States

RECRUITING

Research Site

Nashville, Tennessee, 37203, United States

RECRUITING

Research site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Beijing, Beijing Municipality, 100000, China

RECRUITING

Research Site

Beijing, Beijing Municipality, 100021, China

RECRUITING

Research Site

Beijing, Beijing Municipality, 100142, China

RECRUITING

Research Site

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Research Site

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Research Site

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

781-918-6670clinicaltrials@jacobiopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 26, 2024

Study Start

July 24, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

CN(6)US(7)