Recruiting
Phase 1
Phase 2

JAB-30355

Sponsor:

Jacobio Pharmaceuticals Co., Ltd.

Code:

NCT06386146

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JAB-30355

JAB-30355

Study Details

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.

Conditions

Solid Tumors

Study ID

NCT06386146

Start date

Jul 24, 2024

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

144 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation phase

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

experimental: Dose expansion phase

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

Interventions

JAB-30355

Oral administration

JAB-30355

Oral administration

Primary outcome measure

  • Dose limiting toxicity (DLT) [ Time Frame: Approximately one year ]
  • Number of participants with adverse events [ Time Frame: Approximately three years ]

Central Contacts and Locations

Central contacts

Jacobio Pharmaceuticals

781-918-6670clinicaltrials@jacobiopharma.com

Locations

Research Site

Recruiting

Denver, Colorado, United States, 80218

Research site

Recruiting

St Louis, Missouri, United States, 63110

Research site

Recruiting

Cleveland, Ohio, United States, 44195

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research site

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jacobio Pharmaceuticals Co., Ltd. on 2026-05-22.