Advanced Solid Tumors study: JAB-23E73 vs Cetuximab
Official title JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
ClinicalTrials.gov ID: NCT06973564
What this study is testing
What is JAB-23E73?
an investigational oral medicine being studied as a potential treatment for advanced solid tumors with KRAS alterations. is designed to inhibit KRAS proteins and block downstream signaling pathways that promote tumor growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether JAB-23E73 is safe and tolerable for people with advanced solid tumors.
- Who it's for
- You may be able to join if you are an adult who has advanced solid tumors.
- What's involved
- You would receive JAB-23E73 by itself or together with other medicines. You will have doctor visits and tests to check how you feel.
- Time commitment
- The study lasts several months and includes regular clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 and who have...
- Histologically/cytologically confirmed unresectable locally advanced or metastatic CRC who progressed on or were intolerant to ≥1 standard systemic...
- Patients must have KRAS alterations.
You likely can't join if
- Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the...
- Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-RAS/pan-KRAS/multi-KRAS inhibitors, or similar agents.
- Participants who have previously been treated with cetuximab or other EGFR antibodies (Part B1 only).
- 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.
See the full eligibility 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 and who have received relevant prior systemic therapy.(Part A)
- Histologically/cytologically confirmed unresectable locally advanced or metastatic CRC who progressed on or were intolerant to ≥1 standard systemic regimen with fluorouracil derivatives, oxaliplatin, irinotecan...
- 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.
- 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, pan-RAS/pan-KRAS/multi-KRAS inhibitors, or similar agents.
- Participants who have previously been treated with cetuximab or other EGFR antibodies (Part B1 only).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, Minnesota, United States; St Louis, Missouri, United States; Cleveland, Ohio, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.