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Metastatic Colorectal CarcinomaPhase 1/2NCT07791758

A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma

A Phase 1/2 study testing LBL-024 for Injection, Bevacizumab injection and Oxaliplatin injection in people with Metastatic Colorectal Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 10 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Carcinoma
What is being tested?
LBL-024 for Injection, Bevacizumab injection and Oxaliplatin injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
10 sitesChina
Study dates
28 Sep 2026to 4 Sep 2030
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

  • Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
  • Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
  • The expected survival time is at least 12 weeks.
  • According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.
  • There is adequate organ and bone marrow function,Conforms to laboratory test results.
  • Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.

Who cannot join

  • Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
  • Women during pregnancy or lactation.
  • Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.
  • participant had a history of severe cardiovascular and cerebrovascular disorder.
  • Subjects who received a live vaccine within 4 weeks prior to the first dose or are scheduled to receive a live vaccine during the study treatment period and within 4 weeks after the last dose.
  • patients with active,Or patients who have had and may recur autoimmune diseases.
Show all 9Show fewer
  • patients with active hepatitis B or active hepatitis C.
  • History of immunodeficiency including HIV antibody test positive.
  • The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Xu contact

025-83378099

liulei@leadsbiolabs.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Lei Lui, 025-83378099, liulei@leadsbiolabs.com

    Recruiting

  • The Sixth Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Lei Liu, 02583378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471023

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530200

    Lei Liu, 025-83378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • Shanghai GoBroad Cancer Hospital

    Shanghai, Shanghai Municipality, 201300

    Lei Liu, 02583378099, liulei@leadsbiolabs.com

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Lei Liu, 02583378099, liulei@leadsbiolabs.com

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma

This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.

Read the detailed description

This study included phase Ib (safety introduction period) and phase II (randomized controlled extension period).

Phase Ib and Phase II each contain two independent cohorts, Cohort 1 and Cohort 2.

After comprehensive evaluation by the sponsor and investigator, the safety and tolerability of combination therapy in Phase Ib Cohort 1 and Cohort 2 were good, and preliminary efficacy was observed,Participants will be enrolled to conduct the two cohorts of phase II study.The Phase II study design will be adjusted based on results from the Phase Ib study.The population enrolled in Cohort 1 of Phase II will be determined by the results of Cohort 1A and Cohort 1B of Phase Ib.In Cohort 2 of Phase II, eligible participants were randomly assigned to the B1 group and B2 group in a 2: 1 ratio.

Being tested
LBL-024 for Injection, Bevacizumab injection, Oxaliplatin injection, Capecitabine tablets, Fruquintinib Capsules
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBL-024 for InjectionDrug

    Also called LBL-024

    intravenous infusion.

  • Bevacizumab injectionDrug

    Also called Bevacizumab

    intravenous infusion.

  • Oxaliplatin injectionDrug

    Also called Oxaliplatin

    intravenous infusion.

  • Capecitabine tabletsDrug

    Also called Capecitabine

    Oral.

  • Fruquintinib CapsulesDrug

    Also called fruquintinib

    Oral.

Study groups in NCT07791758
Study groupRoleWhat they receive
LBL-024 + bevacizumabExperimentalLBL-024 + bevacizumab. Intravenous infusion.
Receives: Drug: LBL-024 for Injection; Drug: Bevacizumab injection
LBL-024 + bevacizumab + oxaliplatin + capecitabineExperimentalLBL-024 + bevacizumab + oxaliplatin + capecitabine. Intravenous infusion and Oral .
Receives: Drug: LBL-024 for Injection; Drug: Bevacizumab injection; Drug: Oxaliplatin injection; Drug: Capecitabine tablets
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapyExperimentalLBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy. Intravenous infusion or Oral .
Receives: Drug: LBL-024 for Injection; Drug: Bevacizumab injection; Drug: Fruquintinib Capsules
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabineExperimentalLBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine. Intravenous infusion and Oral .
Receives: Drug: LBL-024 for Injection; Drug: Bevacizumab injection; Drug: Oxaliplatin injection; Drug: Capecitabine tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Occurrence of adverse event (AE) and serious adverse event (SAE)

    Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary outcomes (7)

  1. Disease Control Rate(DCR）

    Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Duration of Response(DOR）

    DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  3. Progression-free Survival(PFS)

    According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  4. Overall survival (OS)

    Time from randomization to death for any reason in a clinical trial.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  5. Cmax

    Maximum drug concentration in plasma after administration.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  6. Tmax

    After administration,Time to reach maximum drug concentration in plasma.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

  7. Immunogenicity

    The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start28 Sep 2026
  3. Primary completion4 Sep 2030 (estimated)
  4. Study completion4 Sep 2030 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
369 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791758
Sponsor's protocol ID
LBL-024-CN008
Status last verified
Oct 2026
First submitted
25 Aug 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LBL-024 for Injection, Bevacizumab injection and Oxaliplatin injection in people with Metastatic Colorectal Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 10 sites 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 Ruihua Xu (025-83378099, liulei@leadsbiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)). The study lists 2 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 NCT07791758.

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 16 Oct 2026.

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