Menu
Recruiting NCT06973564

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

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-23E73, JAB-23E73, JAB-23E73.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration

Overview

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

Detailed description

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.

Interventions

  • Drug JAB-23E73
    Oral administration
  • Drug JAB-23E73
    Oral administration
  • Drug JAB-23E73
    Oral administration

Primary outcome measures

  • Dose Escalation (Phase 1a): Determine the Maximum tolerated dose (MTD) of JAB-23E73 monotherapy. [Time frame: Up to 1 year]
  • Dose Escalation (Phase 1a): Evaluate the overall safety and tolerability of JAB-23E73. [Time frame: Up to 2 years]
  • Dose Expansion/Optimization (Phase 1b): Determine the Recommended Phase 2 Dose (RP2D) of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors. [Time frame: Up to 2 years]
  • 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. [Time frame: Up to 3 years]
  • Dose Expansion/Optimization (Phase 1b): Determine the RP2D of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors. [Time frame: Up to 2 years]
  • 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. [Time frame: Up to 3 years]
Secondary outcome measures (5)
  • Dose Escalation (Phase 1a): Overall Response Rate (ORR) [Time frame: Up to 2 years]
  • Dose Escalation (Phase 1a): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) [Time frame: Up to 2 years]
  • Dose Expansion/Optimization (Phase 1b): Overall Response Rate (ORR) [Time frame: Up to 2 years]
  • Dose Expansion/Optimization (Phase 1b): Evaluate the overall safety and tolerability of JAB-23E73. [Time frame: Up to 2 years]
  • Dose Expansion/Optimization (Phase 1b): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) [Time frame: Up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Mayo Clinic — Rochester
  • Washington University — St Louis
  • Cleveland Clinic Foundation — Cleveland
  • Huntsman Cancer Institute — Salt Lake City

Identifiers

NCT: NCT06973564 · JAB-23E73-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗