NCT06973564

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for phase_1

Timeline
22mo left

Started May 2025

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
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 Progress35%
May 2025Feb 2028

First Submitted

Initial submission to the registry

April 24, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

May 29, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 16, 2026

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

April 24, 2025

Last Update Submit

January 14, 2026

Conditions

Advanced Solid Tumors

Keywords

KRASKRAS mutationKRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12DPan-KRASTargeted TherapyNSCLCPancreas cancerColorectal cancerKRAS-mutant tumorJAB-23E73

Outcome Measures

Primary Outcomes (6)

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

    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.

    Up to 1 year

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

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

    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.

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

    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.

    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.

    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.

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

    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.

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

    Up to 3 years

Secondary Outcomes (5)

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

    Up to 2 years

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

    Up to 2 years

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

    Up to 2 years

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

    Up to 2 years

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

    Up to 2 years

Study Arms (3)

Dose Escalation (Phase 1a)

EXPERIMENTAL

Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.

Drug: JAB-23E73

Dose Expansion / Optimization Phase (Phase 1b)

EXPERIMENTAL

Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors

Drug: JAB-23E73

Indication Expansion (Phase 2a)

EXPERIMENTAL

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.

Drug: JAB-23E73

Interventions

JAB-23E73DRUG

Oral administration

Dose Escalation (Phase 1a)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

(781) 918-6670clinicaltrials@jacobiopharma.com

Study Design

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

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 15, 2025

Study Start

May 29, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

January 16, 2026

Record last verified: 2025-11

Locations

US(4)