A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

Nanjing Leads Biolabs

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: LBL-024 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05170958

LBL-024-CN001

Details and patient eligibility

About

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Full 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 IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.

This trial includes two parts:

Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.

Part II:Phase IIb is a pivotal single-arm clinical study.

Enrollment: 396 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
2. 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
4. The expected survival time is at least 12 weeks
5. ECOG score is 0-1
6. Males with fertility and females of childbearing age are willing to take 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.

Exclusion criteria

1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
3. medical history of immunodeficiency including positive HIV antibody test;
4. Women who are pregnant or breastfeeding;
5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

396 participants in 1 patient group

LBL-024

Experimental group

Description:

LBL-024 injection; Initial dose - MTD; Q3W

Treatment:

Drug: LBL-024 for Injection