Metastatic Colorectal Cancer (mCRC)Phase 1/2NCT07391566
LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
A Phase 1/2 study testing LPM6690176, Bevacizumab and FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) in people with Metastatic Colorectal Cancer (mCRC), run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and Bevacizumab in patients with RAS mutant metastatic colorectal cancer (mCRC), to observe the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- LPM6690176, Bevacizumab and FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide a signed informed consent;
- Age ≥ 18 years and ≤ 75 years, both male and female;
- Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation;
- 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.
Who cannot join
- 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;
- Malignant tumors other than mCRC within 5 years before signing the informed consent;
- Patients who did not recover from the AE of previous anti-tumor treatment to ≤ Grade 1;
- Patients with body cavity effusion requiring local treatment or poorly controlled effusion;
- Symptomatic brain metastasis, history of spinal cord compression or meningeal metastasis;
- 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.
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- 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.;
- 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.;
- Current or past significant risk of bleeding;
- Use of prohibited medication or therapy within the specified time;
- History of drug abuse or alcoholism;
- Known hypersensitivity to any component of any investigational product;
- Pregnant and lactating women;
- Other conditions that may increase the risk of the study or interfere with study results, in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Cancer Hospital
Beijing
Lin Shen, Doctor, 0086-10-88196561, doctorshenlin@sina.cn
About this study
Official title: Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LPM6690176 Capsules in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and Bevacizumab in patients with RAS mutant metastatic colorectal cancer (mCRC), to observe the dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D); Phase 2 is planned to preliminarily evaluate the efficacy of LPM6690176 capsule in combination with chemotherapy + Bev vs. chemotherapy + Bev in patients with previously untreated, RAS mutant mCRC.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- LPM6690176, Bevacizumab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM6690176Drug
LPM6690176 orally.
BevacizumabBiological
Bevacizumab intravenously
FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)Drug
FOLFIRI intravenously
| Study group | Role | What they receive |
|---|---|---|
| LPM6690176 24 mg/m2 | Experimental | LPM6690176 capsules administered 24 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab Receives: Drug: LPM6690176; Biological: Bevacizumab; Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) |
| LPM6690176 36 mg/m2 | Experimental | LPM6690176 capsules administered 36 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab Receives: Drug: LPM6690176; Biological: Bevacizumab; Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) |
| LPM6690176 42 mg/m2 | Experimental | LPM6690176 capsules administered 42 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab Receives: Drug: LPM6690176; Biological: Bevacizumab; Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose-limiting toxicities (DLTs)
Measured: From the first dose of study drug treatment through Cycle 1 (28 days)
Phase Ib: Maximum tolerated dose (MTD)
Measured: From the first dose of study drug treatment through Cycle 1 (28 days)
Phase 1b: Recommended Phase 2 Dose (RP2D)
Measured: From the first dose of study drug treatment through Cycle 1 (28 days)
Phase 2: Overall response rate (ORR)
Measured: Approximately 2 years
Secondary outcomes (11)
Phase 1b: Overall response rate (ORR)
Measured: Approximately 2 years
Duration of response (DOR)
Measured: Approximately 2 years
Disease control rate (DCR)
Measured: Approximately 2 years
Progression-free survival (PFS)
Measured: Approximately 2 years
Overall survival (OS)
Measured: Approximately 2 years
Maximum plasma concentration (Cmax)
Measured: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)
Time to maximum plasma concentration (Tmax)
Measured: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)
Area under the plasma concentration-time curve (AUC)
Measured: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)
Elimination half-life (t1/2)
Measured: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)
Trough observed plasma concentration (Ctrough)
Measured: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 19 (Approximately 20 days, each cycle is 28 days)
Adverse Events (AEs)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391566
- Sponsor's protocol ID
- LY01024/CT-CHN-102
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No