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

NCT05102006 | Completed Phase 1 DMC

• 1 other identifier: LBL-007-CN-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• 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

  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)

• 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.

  During the first Cycles(each cycle is 21 days)

• 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 .

  During the first Cycles(each cycle is 21 days)

Secondary Outcomes (6)

• Number of subjcects with adverse events and serious adverse events

  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)

• Disease Control Rate(DCR)

  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)

• Duration of Response(DOR)

  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)

• Cmax

  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)

• Tmax

  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)

Study Arms (1)

LBL-007&Toripalimab

EXPERIMENTAL

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

Drug: LBL-007 Injection; Drug: Toripalimab Injection

Interventions

LBL-007 Injection DRUG

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

Also known as: LBL-007

LBL-007&Toripalimab

Toripalimab Injection DRUG

Toripalimab Injection; dose C; Q3W

Also known as: Toripalimab

LBL-007&Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (14)

The first affiliated hospital of bengbu medical University

Bengbu, Anhui, 233060, China

Location

Chongqing University Three gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

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

Fuzhou, Fujian, 351100, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The First People's Hospital of Yu Lin

Yulin, Guangxi, 537000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Changzhou Cancer Hospital

Changzhou, Jiangsu, 213000, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272007, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276000, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• li zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: November 30, 2021
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)