A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
Study Details
Study Description
Brief Summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase II indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, receptor occupancy (RO), immunogenicity and preliminary efficacy.
This trial includes two parts: phase I study phase and phase II study phase.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Evaluation of LBL-024 Phase I/II study in patients with advanced solid tumors Starting from the dose A , And then dose B, dose C, doseD, doseE, and dose F Q3W. |
Drug: LBL-024 for Injection
LBL-024 was given every three weeks for treatment
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose (MTD) [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment
- Dose-limiting toxicities（DLT) [Within 3 weeks after receiving the first dose of the test drug]
During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related)
Secondary Outcome Measures
- Adverse events and serious adverse events [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
Laboratory examination, physical examination, vital signs and electrocardiogram, etc.
- Maximum serum concentration (Cmax) [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
To determine the PK profile of LBL-024
- Immunogenicity [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)
- Objective Response Rate (ORR) [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）]
Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1
- Disease Control Rate(DCR) [Visit 30 days after discontinuation of treatment or withdraw from the visit]
Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
-
18-75 years old (including boundary value), no gender limit;
-
previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
-
The expected survival time is at least 12 weeks
Exclusion Criteria:
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Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
-
Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
-
Women who are pregnant or breastfeeding;
-
The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
| 2 | Chongqing Cancer Hospital | Chongqing | Chongqing | China | 400030 |
| 3 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450003 |
| 4 | Hubei Cancer Hospital | Wuhan | Hubei | China | 430079 |
| 5 | Hunan Cancer Hospital | Changsha | Hunan | China | 410031 |
| 6 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | 210008 |
| 7 | The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310003 |
| 8 | Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Nanjing Leads Biolabs Co.,Ltd
Investigators
- Principal Investigator: lin Shen, Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LBL-024-CN001