A Phase 1/2 interventional study of LBL-024 for Injection and Bevacizumab injection in Metastatic Colorectal Carcinoma, sponsored by Nanjing Leads Biolabs Co.,Ltd. Recruiting at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Nanjing Leads Biolabs Co.,Ltd · Phase 1/2, Interventional, and Treatment
Among 1,132 studies in Colorectal Neoplasms with a site in China — 526 open to participants now, 602 under way, 67 of them phase 3. Colorectal Neoplasms · China.
Among the 1,132 studies in Colorectal Neoplasms with a site in China, this one is the 126th largest by planned enrollment of the 888 interventional ones, is one of 112 that started in 2026, is one of 94 in phase 1/2, reaches primary completion later than 590 of the 601 other live ones, and was the 1,106th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 369 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →526 of the 1,132 studies in Colorectal Neoplasms with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →1,132 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 112 started in 2026.
Median enrollment 80 across the 888 interventional studies, 400 across the 242 observational. Of the 212 that completed or were terminated, 27 (13%) have results posted.
247 of 1,132 have an industry lead sponsor. The 10 most frequent:
Nanjing Leads Biolabs Co.,Ltd is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
Nanjing Leads Biolabs Co.,Ltd has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
145 of the studies in Colorectal Neoplasms with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008119Phase 3Shanghai Kechow Pharma, Inc.Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer | 2026-12-24 |
| NCT05171660Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer | 2026-12-30 |
| NCT03303495Phase 3Sun Yat-sen UniversityA Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC | 2026-12-31 |
| NCT06280495Phase 3Sun Yat-sen UniversityNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients | 2026-12-31 |
| NCT05086614Phase 3Fudan UniversityThymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer | 2027-03-31 |
Among the 1,132 studies in Colorectal Neoplasms with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LBL-024 + bevacizumab. Intravenous infusion.
Drug: LBL-024 for Injection · Drug: Bevacizumab injection
LBL-024 + bevacizumab + oxaliplatin + capecitabine. Intravenous infusion and Oral .
Drug: LBL-024 for Injection · Drug: Bevacizumab injection · Drug: Oxaliplatin injection · Drug: Capecitabine tablets
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy. Intravenous infusion or Oral .
Drug: LBL-024 for Injection · Drug: Bevacizumab injection · Drug: Fruquintinib Capsules
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine. Intravenous infusion and Oral .
Drug: LBL-024 for Injection · Drug: Bevacizumab injection · Drug: Oxaliplatin injection · Drug: Capecitabine tablets
intravenous infusion.
Also known as: LBL-024
intravenous infusion.
Also known as: Bevacizumab
intravenous infusion.
Also known as: Oxaliplatin
Oral.
Also known as: Capecitabine
Oral.
Also known as: fruquintinib
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).
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)
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.
Time frame: 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)
Disease Control Rate(DCR）
Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.
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)
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.
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)
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.
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)
Overall survival (OS)
Time from randomization to death for any reason in a clinical trial.
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)
Cmax
Maximum drug concentration in plasma after administration.
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)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
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)
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.
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)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2030, 47 months after the start.
Of 158 industry-sponsored phase 1/2 interventional studies under Colorectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 47 months is below that.
Counting every sponsor, half of 260 studies reached it within 59 months; a quarter within 36 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Anti-PD-L1/4-1BB Bispecific Antibody LBL-024
Nanjing Leads Biolabs Co.,Ltd