Clinical trial · Interventional
A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors
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
NCT05102006CI-TRIAL-00090501completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBL-007 Injection | Drug | — | UNRESOLVED |
| Toripalimab Injection | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-007&Toripalimab
- description
- LBL-007 Injection; dose A or dose B; Q3W Toripalimab Injection; dose C; Q3W
- interventionNames
- Drug: LBL-007 Injection
- Drug: Toripalimab Injection
Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 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)
- description
- 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
- measure
- Dose-limiting toxicities(DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form. 2. Age ≥ 18 and ≤ 75 years at the time of signing the informed consent, regardless of gender. 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1. 4. The expected survival time is at least 12 weeks. 5. 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. Exclusion Criteria: 1. Have received other unmarketed clinical investigational drugs or treatments within 4 weeks prior to the first dose of study drug. 2. 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.. 3. Patients with active infection and currently requiring intravenous anti-infective therapy. 4. Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention. 5. The patient has a Medical history of immunodeficiency, including HIV antibody positive. 6. Active hepatitis B or active hepatitis C. 7. Women during pregnancy or lactation. 8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.