NCT07640295

Brief Summary

The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
54mo left

Started Jun 2026

Longer than P75 for phase_1

Geographic Reach
1 country

13 active sites

Status
not yet 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 Progress2%
Jun 2026Dec 2030

First Submitted

Initial submission to the registry

June 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

June 4, 2026

Last Update Submit

June 8, 2026

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

KRASKRAS mutationKRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A,Pan-KRASPancreatic ductal adenocarcinomaKRAS-mutant tumorTargeted TherapyJAB-23E73

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicities (DLT)

    The number and proportion of participants who experienced dose-limiting toxicities (DLT).

    Up to 28 days

  • Adverse events.safety evaluation

    The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.

    Up to approximately 3 years

Secondary Outcomes (9)

  • ORR

    Up to approximately 3 years

  • DOR

    Up to approximately 3 years

  • TTR

    Up to approximately 3 years

  • PFS

    Up to approximately 3 years

  • DCR

    Up to approximately 3 years

  • +4 more secondary outcomes

Study Arms (1)

Dose escalation/backfill

EXPERIMENTAL
Drug: JAB-23E73 tablet，nab-paclitaxel，gemcitabine

Interventions

JAB-23E73 tablet，nab-paclitaxel，gemcitabineDRUG

Orally, intravenous (IV) infusion

Dose escalation/backfill

Eligibility Criteria

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

You may qualify if:

  • Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
  • \. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
  • \. ECOG performance status score of 0 or 1. 6. Adequate organ function.

You may not qualify if:

  • Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
  • A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
  • Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS inhibitors, or other agents of the same class.
  • Primary central nervous system (CNS) tumors.
  • Women who are pregnant or breast-feeding.
  • Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, China

Location

ShanXi Cancer Hospital

Taiyuan, China

Location

Hubei Province Hospital

Wuhan, China

Location

Wuhan Union Hospital Of China

Wuhan, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

The First Affiliated hospital of Zhengzhou University

Zhengzhou, China

Location

Study Officials

  • Jacobio Pharmaceuticals

    Jacobio Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

86 10 56315466clinicaltrials@jacobiopharma.com

Study Design

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

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 10, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(13)