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Advanced Malignant TumorsPhase 1/2NCT05102006

A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors

A Phase 1/2 study testing LBL-007 Injection and Toripalimab Injection in people with Advanced Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm, open-label, multicenter Phase Ib/II clinical study to evaluate the safety, tolerability, PK characteristics, immunogenicity and efficacy of LBL-007 in combination with Toripalimab in Treatment of Advanced Malignant Tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Tumors
What is being tested?
LBL-007 Injection and Toripalimab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
14 sitesChina
Study dates
30 Nov 2021to 22 May 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 and visit schedule, voluntarily enroll in the study, and sign the written informed consent form.
  • Age ≥ 18 and ≤ 75 years at the time of signing the informed consent, regardless of gender.
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
  • The expected survival time is at least 12 weeks.
  • Males with fertility 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 (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）;Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Who cannot join

  • Have received other unmarketed clinical investigational drugs or treatments within 4 weeks prior to the first dose of study drug.
  • Use of immunomodulatory drugs within 14 days before the first use of the study drug, including but not limited to thymopeptide, interleukin-2, interferon, etc..
  • Patients with active infection and currently requiring intravenous anti-infective therapy.
  • Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
  • The patient has a Medical history of immunodeficiency, including HIV antibody positive.
  • Active hepatitis B or active hepatitis C.
  • Women during pregnancy or lactation.
  • 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

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • The first affiliated hospital of bengbu medical University

    Bengbu, Anhui, 233060

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Changzhou Cancer Hospital

    Changzhou, Jiangsu, 213000

  • Chongqing University Three gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Fuzhou, Fujian, 351100

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272007

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First People's Hospital of Yu Lin

    Yulin, Guangxi, 537000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Toripalimab in the Treatment of Advanced Malignancies

This is a single-arm, open-label, multicenter Phase Ib/II clinical study to evaluate the safety, tolerability, PK characteristics, immunogenicity and efficacy of LBL-007 in combination with Toripalimab in Treatment of Advanced Malignant Tumors.

Read the detailed description

This trial is divided into combination dose escalation phase (Phase Ib) and combination dose expansion phase (Phase II), as follows:

  1. In the Phase Ib study, patients with advanced neoplasm malignant who have no standard treatment or have treatment failure of standard treatment or are not suitable for standard treatment at present stage are planned to be enrolled,including patients with advanced neoplasm malignant who have not been treated with anti-PD- (L) 1 antibody or have progressed or not tolerated after treatment with anti-PD- (L) 1 antibody.LBL-007 is administered once every 3 weeks (Q3W),intravenous infusion.The dosing regimen of toripalimab in combination was once every 3 weeks (Q3W),Intravenous infusion.
  2. According to the LBL-007 global research and development data and the safety, tolerability and PK data of the phase Ib clinical study, the recommended dose of phase II clinical study (RP2D) was obtained for the expansion of target indications.This study is designed to enroll patients with advanced neoplasm malignant, including patients who have not been treated with anti-PD- (L) 1 antibody or patients who have progressed or intolerant after treatment with anti-PD- (L) 1 antibody.Subjects need to undergo relevant examinations or observations during the screening period,and subjects who meet the screening requirements will enter the treatment period.
  3. Biological samples will be collected from subjects in Phase Ib/II for relevant testing in this trial.Phase Ib is expected to enroll approximately 9-12 subjects.Phase II is expected to enroll approximately 200 subjects.The number of subjects to be enrolled was determined by actual conditions.
Being tested
LBL-007 Injection, Toripalimab Injection

What participants receive

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

  • LBL-007 InjectionDrug

    Also called LBL-007

    LBL-007 Injection; dose A or dose B; Q3W

  • Toripalimab InjectionDrug

    Also called Toripalimab

    Toripalimab Injection; dose C; Q3W

Study groups in NCT05102006
Study groupRoleWhat they receive
LBL-007&ToripalimabExperimentalLBL-007 Injection; dose A or dose B; Q3W Toripalimab Injection; dose C; Q3W
Receives: Drug: LBL-007 Injection; Drug: Toripalimab Injection

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) or Lugano 2014 (lymphoma),Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase II

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Dose-limiting toxicities（DLT）

    DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.DLT is defined as toxicity (possible adverse events related to LBL-007) during the DLT observation period (3 weeks after the first dose).It was used to evaluate the safety in Phase Ib.

    Measured: During the first Cycles(each cycle is 21 days)

  3. Maximum tolerated dose (MTD)

    MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase Ib .

    Measured: During the first Cycles(each cycle is 21 days)

Secondary outcomes (6)

  1. Number of subjcects with adverse events and serious adverse events

    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-007 and Toripalimab will be assessed by monitoring the Adverse event (AE).

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Disease Control Rate(DCR)

    Percentage of participants achieving CR, PR, iCR, iPR 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  3. Duration of Response(DOR)

    DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  4. 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  5. 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  6. 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 (30+7 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 posted1 Nov 2021
  2. Study start30 Nov 2021
  3. Primary completion22 May 2024
  4. Study completion22 May 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102006
Sponsor's protocol ID
LBL-007-CN-003
Status last verified
May 2025
First submitted
20 Oct 2021
Last updated
3 Jun 2025
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-007 Injection and Toripalimab Injection in people with Advanced Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 14 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)). The study lists 3 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 NCT05102006.

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 3 Jun 2025.

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