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NCT Number: NCT06959615

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

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.

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Key information

Conditions

Advanced Solid Tumor Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JAB-23E73

Drug

Administered orally

Primary outcomes

  1. Phase 1: Number of participants with dose limiting toxicities (DLT)

    Time frame: Up to 21 days

    Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

  2. Phase 2a: Objective response rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is defined as the proportion of patients with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1.

Secondary outcomes

  1. Phase 1/2a: Adverse events

    Time frame: Up to approximately 2 years

    Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs)

  2. Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73

    Time frame: Up to approximately 2 years

    PK: Cmax of JAB-23E73

  3. Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73

    Time frame: Up to approximately 2 years

    PK: Tmax of JAB-23E73

  4. Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73

    Time frame: Up to approximately 2 years

    PK: AUC of JAB-23E73

  5. Phase 1: ORR

    Time frame: Up to approximately 2 years

    ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1.

  6. Phase 1/2a: Time to Response (TTR)

    Time frame: Up to approximately 2 years

    TTR is defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1

  7. Phase 1/2a: Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years

    PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

  8. Phase 1/2a: Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

    DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) as assessed by the investigator per RECIST v1.1

  9. Phase 1/2a: Duration of Response (DoR)

    Time frame: Up to approximately 2 years

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

  10. Phase 2a: Overall Survival (OS)

    Time frame: Up to approximately 2 years

    OS is defined as the time from the date of first dose of study drug until the date of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacobio Pharmaceuticals

CONTACT

[email protected]

86 10 56315466

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 6, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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