New pill combo aims to tackle Hard-to-Treat colorectal cancer
NCT ID NCT07391566
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a new oral drug, LPM6690176, added to standard chemotherapy and bevacizumab for people with a specific type of advanced colorectal cancer (RAS mutation). The first part finds the safest dose, and the second part compares the new combo against standard treatment alone. About 99 adults who have not had prior therapy for metastatic disease will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LPM6690176 capsules combined with chemotherapy (FOLFIRI) and bevacizumab
- What this could lead to
- If successful, this could offer a new first-line treatment option for people with RAS-mutant metastatic colorectal cancer, potentially improving tumor shrinkage and delaying progression.
- What could go wrong
- This is an early-phase trial (Phase 1b/2) with only 99 participants, so safety and effectiveness are not yet proven. The drug combination may cause significant side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Mar 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to provide a signed informed consent; 2. Age ≥ 18 years and ≤ 75 years, both male and female; 3. Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation; 4. Prior therapies for colorectal cancer: (1 ) For phase 1b patients: who have failed or intolerable to prior first-line therapy; (2) For phase 2 patients: who have not received prior systemic therapy for metastatic colorectal cancer. 5\. At least one measurable lesion according to RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 7. Life expectancy≥ 6 months; 8. Adequate bone marrow and organ function; 9. Negative pregnancy test for women of childbearing potential. patients of childbearing potential should take effective contraceptive measures during study drug treatment and until 6 months after initiation of investigational product. Exclusion Criteria: 1. Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) who are suitable for immune checkpoint inhibitor therapy as assessed by the investigator; 2. Malignant tumors other than mCRC within 5 years before signing the informed consent; 3. Patients who did not recover from the AE of previous anti-tumor treatment to ≤ Grade 1; 4. Patients with body cavity effusion requiring local treatment or poorly controlled effusion; 5. Symptomatic brain metastasis, history of spinal cord compression or meningeal metastasis; 6. Underwent other therapeutic surgery other than diagnosis, biopsy, drainage, or expected to require major surgery during the study, or had unhealed wound, ulcer or fracture. 7. Current or previous uncontrolled concomitant non-gastrointestinal disease including, but not limited to myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, serious arrhythmia, current uncontrolled hypertension, previous history of hypertensive crisis or hypertensive brain disease, tumor invasion into major blood vessels, interstitial lung disease, interstitial pneumonia, pulmonary interstitial fibrosis, reversible posterior leukoencephalopathy syndrome (RPLS), etc.; 8. Current or past presence of the gastrointestinal abnormalities, including but not limited to active peptic ulcer, clinically significant gastrointestinal abnormalities prior to informed consent, active colitis, long-term anticoagulant therapy, antiplatelet therapy, etc.; 9. Current or past significant risk of bleeding; 10. Use of prohibited medication or therapy within the specified time; 11. History of drug abuse or alcoholism; 12. Known hypersensitivity to any component of any investigational product; 13. Pregnant and lactating women; 14. Other conditions that may increase the risk of the study or interfere with study results, in the judgment of the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic colorectal cancer (MCRC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Cancer Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a vitamin b derivative boost chemo for advanced colon cancer?
- Exercise may boost Well-Being in advanced colorectal cancer patients
- Real-World study tests fruquintinib for Tough-to-Treat colorectal cancer
- Can a targeted drug keep working after cancer progresses? new trial aims to find out
- Promising drug duo targets Hard-to-Treat HER2 cancers
- New drug combo aims to extend life in tough colorectal cancer