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JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration

NCT ID: NCT06973564

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2028-02-29

Brief Summary

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This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors

Detailed Description

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Study JAB-23E73-1002 is a multicenter, open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b. The indication expansion phase will further explore the efficacy and safety in advanced KRAS-alternated tumors which consist of 3 cohorts: Cohort C1, the CRC cohort; Cohort C2, the PDAC cohort; and Cohort C3, other solid tumor cohort.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation (Phase 1a)

Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.

Group Type EXPERIMENTAL

JAB-23E73

Intervention Type DRUG

Oral administration

Dose Expansion / Optimization Phase (Phase 1b)

Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors

Group Type EXPERIMENTAL

JAB-23E73

Intervention Type DRUG

Oral administration

Indication Expansion (Phase 2a)

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.

Group Type EXPERIMENTAL

JAB-23E73

Intervention Type DRUG

Oral administration

Interventions

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JAB-23E73

Oral administration

Intervention Type DRUG

JAB-23E73

Oral administration

Intervention Type DRUG

JAB-23E73

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent.
* Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
* Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions.
* Patients must have KRAS alterations.
* Participants are required to provide an archived tumor sample.
* Patients with a life expectancy ≥3 months.
* ECOG performance status score of 0 or 1.
* Patients must have at least one measurable lesion as defined by RECIST v1.1.

Exclusion Criteria

* Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug.
* Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, or pan/multi-KRAS inhibitors.
* Known serious allergy to JAB-23E73 or excipient.
* Patients with primary central nervous system tumors.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention.
* QT interval\>470 msec.
* LVEF ≤50% assessed by ECHO or MUGA.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacobio Pharmaceuticals

Role: CONTACT

Phone: (781) 918-6670

Email: [email protected]

Other Identifiers

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JAB-23E73-1002

Identifier Type: -

Identifier Source: org_study_id