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JAB-23E73 for Advanced Solid Tumors with KRAS Alteration

This study is testing a new oral medication called JAB-23E73 for adults with advanced solid tumors that have a specific genetic change called a KRAS alteration. The main goals are to find the safest and most effective dose of JAB-23E73 and to understand its safety and how well it works. To join, you must be at least 18 years old, have advanced solid tumors that cannot be cured by other treatments, and your tumor must have a KRAS alteration. Researchers will also look at how the drug moves through your body and its effects on the tumor. This study is currently recruiting about 294 participants.

Study design
This is an open-label, multi-center Phase 1/2a study. It will involve a dose-escalation phase, followed by dose-expansion and indication expansion phases.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be evaluated for up to 2 years, and the maximum tolerated dose will be determined within 1 year.

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NCT06973564

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jacobio Pharmaceuticals Co., Ltd.
~294 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:JAB-23E73

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation (Phase 1a): Determine the Maximum tolerated dose (MTD) of JAB-23E73 monotherapy.
Measured over Up to 1 year
+5 more outcomes measured

Conditions

Advanced Solid Tumors

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Where it's being run

4 sites across 4 states
Minnesota1
Missouri1
Ohio1
Utah1

Who to contact

Jacobio Pharmaceuticals
[email protected]
(781) 918-6670
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

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

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

  • 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.Up to 2 years

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

  • 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.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.

  • Dose Expansion/Optimization (Phase 1b): Determine the RP2D of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors.Up to 2 years

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

  • 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.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.