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NCT Number: NCT06973564

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

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

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Key information

Conditions

Advanced Solid Tumors 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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

JAB-23E73

Drug

Oral administration

Primary outcomes

  1. Dose Escalation (Phase 1a): Determine the Maximum tolerated dose (MTD) of JAB-23E73 monotherapy.

    Time frame: Up to 1 year

    Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) during the first 21 days of treatment. A DLT is defined as any toxicities that meet the criteria for a DLT assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 during the evaluation period at any dose.

  2. Dose Escalation (Phase 1a): Evaluate the overall safety and tolerability of JAB-23E73.

    Time frame: Up to 2 years

    Safety and tolerability of repeated cycles from first drug administration up to the Safety Follow Up Visit (SFUV)

  3. 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

    RP2D determined by MTD, long term tolerability, PK, efficacy and any other relevant data as available.

  4. 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

    ORR, defined as the percentage of patients with the best overall response of confirmed partial response (PR), or complete response (CR) per RECIST v1.1.

  5. 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

    RP2D determined by MTD, long term tolerability, PK, efficacy and any other relevant data as available.

  6. 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

    ORR, defined as the percentage of patients with the best overall response of confirmed PR, or CR per RECIST v1.1.

Secondary outcomes

  1. Dose Escalation (Phase 1a): Overall Response Rate (ORR)

    Time frame: Up to 2 years

    Objective response rate (ORR) defined as the percentage of patients with the best overall response of confirmed partial response (PR), or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  2. Dose Escalation (Phase 1a): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)

    Time frame: Up to 2 years

    Cmax of JAB-23E73

  3. Dose Expansion/Optimization (Phase 1b): Overall Response Rate (ORR)

    Time frame: Up to 2 years

    ORR, defined as the percentage of patients with the best overall response of confirmed PR, or CR per RECIST v1.1.

  4. Dose Expansion/Optimization (Phase 1b): Evaluate the overall safety and tolerability of JAB-23E73.

    Time frame: Up to 2 years

    Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures.

  5. Dose Expansion/Optimization (Phase 1b): Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)

    Time frame: Up to 2 years

    Cmax of JAB-23E73

Study contacts

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

Jacobio Pharmaceuticals

CONTACT

[email protected]

(781) 918-6670

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 15, 2025
Registry last updated
Jan 16, 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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