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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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)
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
Are there results?
Not yet: the study is under way

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.

Lin Shen, Doctor contact

0086-10-88196561

doctorshenlin@sina.cn

China1 site

  • Beijing Cancer Hospital

    Beijing

    Lin Shen, Doctor, 0086-10-88196561, doctorshenlin@sina.cn

Other trials in China

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.

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 groups in NCT07391566
Study groupRoleWhat they receive
LPM6690176 24 mg/m2ExperimentalLPM6690176 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/m2ExperimentalLPM6690176 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/m2ExperimentalLPM6690176 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.

  1. Phase Ib: Dose-limiting toxicities (DLTs)

    Measured: From the first dose of study drug treatment through Cycle 1 (28 days)

  2. Phase Ib: Maximum tolerated dose (MTD)

    Measured: From the first dose of study drug treatment through Cycle 1 (28 days)

  3. Phase 1b: Recommended Phase 2 Dose (RP2D)

    Measured: From the first dose of study drug treatment through Cycle 1 (28 days)

  4. Phase 2: Overall response rate (ORR)

    Measured: Approximately 2 years

Secondary outcomes (11)

  1. Phase 1b: Overall response rate (ORR)

    Measured: Approximately 2 years

  2. Duration of response (DOR)

    Measured: Approximately 2 years

  3. Disease control rate (DCR)

    Measured: Approximately 2 years

  4. Progression-free survival (PFS)

    Measured: Approximately 2 years

  5. Overall survival (OS)

    Measured: Approximately 2 years

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  1. First posted6 Feb 2026
  2. Study start31 Mar 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin Shen, Doctor (0086-10-88196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Dose-limiting toxicities (DLTs) (time frame: From the first dose of study drug treatment through Cycle 1 (28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07391566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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