Clinical trial · Interventional
A Study of EMB-02 in Participants With Advanced Solid Tumors
A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
NCT04618393CI-TRIAL-00077330terminatedPhase 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
Why stopped (as posted): Company's resource optimization and product's development change
Summary
Brief summary (as posted)
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMB-02 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EMB-02
- description
- In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels. In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D.
- interventionNames
- Biological: EMB-02
Primary outcomes (6)
- measure
- Incidence and severity of adverse events as assessed by CTCAE V5.0
- timeFrame
- Screening up to follow-up (30 days after the last dose)
- description
- Incidence and severity of AE.
- measure
- Incidence of serious adverse events (SAE)
- timeFrame
- Screening up to follow-up (30 days after the last dose)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide written informed consent. * Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1 * Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. \> 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1 * Archival tumor samples available for retrospective analysis or biopsy will be taken. * ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy \> 3 Months * Adequate organ function to participate in the trial. * Recovery from adverse events (AEs) related to prior anticancer therapy. * Highly effective contraception Exclusion Criteria: * Patients who have active autoimmune disease or history of autoimmune disease * History of severe irAE. * History of severe allergic reactions * Use of systemic corticosteroids. * Symptomatic central nervous system metastases. * Patients with cardiac dysfunction * Uncontrolled diabetes mellitus with hemoglobin A1c \> 8% (via medical history) * Prior treatment with a LAG-3 inhibitor * Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment; * Prior organ or stem cell/bone marrow transplant. * Concurrent malignancy \< 5 years prior to entry. * Patients with active infections. * Major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment * Live virus vaccines \< 30 days prior to screening * Pregnant or breast-feeding females * Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment * Any other serious underlying medical conditions * Abuse on alcohol, cannabis- derived products or other drugs
References
Publications (2)
- DERIVEDDay D, Ganju V, Chung K, Si L, Mao L, Aghmesheh M, Hoyer R, Brewin K, Zeng S, Zhang M, Lu Q, Jiang C, Ren F, Zhu Y, Guo J. First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors. Br J Cancer. 2025 Jun;132(10):905-912. doi: 10.1038/s41416-025-02990-x. Epub 2025 Apr 15. PMID 40234667
- DERIVEDJiang C, Ren F, Zhang M, Lu Q, Zeng S, Yang G, Zhu Y. Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors. CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):975-986. doi: 10.1002/psp4.70011. Epub 2025 Mar 11. PMID 40067130