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Recruiting NCT06959615

A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

Phase I / Phase II Interventional Advanced Solid Tumor

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.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: No limits · 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
China
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 Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

Overview

This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.

Detailed description

Study JAB-23E73-1001 is a global 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 (dose optimization) and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. Then, two of the alternative dosages of JAB-23E73 will be selected to further evaluate the efficacy, safety and PK in patients with KRAS-alternated NSCLC or other tumors, and patients may be further selected by certain/several types of KRAS-alternations based on dose escalation data. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b.

Interventions

  • Drug JAB-23E73
    Administered orally
  • Drug JAB-23E73
    Administered orally

Primary outcome measures

  • Phase 1: Number of participants with dose limiting toxicities (DLT) [Time frame: Up to 21 days]
  • Phase 2a: Objective response rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (10)
  • Phase 1/2a: Adverse events [Time frame: Up to approximately 2 years]
  • Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73 [Time frame: Up to approximately 2 years]
  • Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73 [Time frame: Up to approximately 2 years]
  • Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73 [Time frame: Up to approximately 2 years]
  • Phase 1: ORR [Time frame: Up to approximately 2 years]
  • Phase 1/2a: Time to Response (TTR) [Time frame: Up to approximately 2 years]
  • Phase 1/2a: Progression Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Phase 1/2a: Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
  • Phase 1/2a: Duration of Response (DoR) [Time frame: Up to approximately 2 years]
  • Phase 2a: Overall Survival (OS) [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
  • Able to provide an archived tumor tissue sample or fresh biopsy sample.
  • Life expectancy ≥3 months at the start of treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • ≥1 measurable lesion per RECIST v1.1.
  • Adequate organ function.

Exclusion criteria

  • Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
  • Previous treatment with rat sarcoma (RAS) targeting agents.
  • Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
  • Impaired cardiovascular function or clinically significant cardiac disease.
  • Mean QT interval corrected using Fridericia's formula (QTcF) >470 msec.
  • Females who are pregnant or breastfeeding.

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

China · 32 centers
  • Anhui Provincial Cancer Hospital — Hefei
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Beijing
  • Beijing Cancer Hospital — Beijing
  • Beijing Chest Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Fujian cancer Hospital — Fuzhou
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
  • … and 24 more centers

Identifiers

NCT: NCT06959615 · JAB-23E73-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗