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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
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- 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.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Lei Liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Lei Lui, 025-83378099, liulei@leadsbiolabs.com
- Not yet 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
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.
- Conditions
- Metastatic Colorectal Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| LBL-024 + bevacizumab | Experimental | LBL-024 + bevacizumab.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Bevacizumab injection |
| LBL-024 + bevacizumab + oxaliplatin + capecitabine | Experimental | LBL-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 monotherapy | Experimental | LBL-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 + capecitabine | Experimental | LBL-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.
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted28 Aug 2026
- Study start28 Sep 2026
- Primary completion4 Sep 2030 (estimated)
- Study completion4 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Principal investigator, Sun Yat-Sen University Cancer Center
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