NCT06973564 · Jacobio Pharmaceuticals Co., Ltd.
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
What this study is about
This study is to evaluate the safety and how well patients handle the treatment of JAB-23E73 in adult participants with advanced solid tumors
View original scientific description
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
Interventions
DRUG
JAB-23E73
Oral administration
DRUG
Cetuximab
Intravenous infusion
Primary outcome measures
Part A: Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) with treatment of JAB-23E73 monotherapy.
Time frame: Up to 1 year
A DLT is defined as any toxicities that meet the criteria for a DLT defined in the protocol
Part A: Safety and tolerability of JAB-23E73 monotherapy
Time frame: Up to 2 years
Incidence, and severity of adverse events and changes in clinical laboratory tests and examinations.
Part A: Objective response rate (ORR) of JAB-23E73 monotherapy.
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.
Part B1: Safety, tolerability and RP2D of JAB-23E73 in combination with cetuximab.
Time frame: Up to 2 years
Incidence, and severity of adverse events and changes in clinical laboratory tests and examinations. RP2D will be determined based on comprehensive available data
Part B1: Objective response rate (ORR) of JAB-23E73 in combination with cetuximab.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
- St Louis, Missouri
- Cleveland, Ohio
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations