Clinical trial · Interventional
A Study of AK130 in Patients With Advanced Malignant Tumors
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors
NCT05653284CI-TRIAL-00079777completedPhase 1ClinicalTrials.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)
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK130 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK130
- description
- Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.
- interventionNames
- Drug: AK130
Primary outcomes (2)
- measure
- Incidence and severity of participants with adverse events (AEs)
- timeFrame
- From time ICF is signed until 90 days after last dose of AK130
- measure
- Number of participants with DLTs
- timeFrame
- During the first four weeks of treatment with AK130
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative. 2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. 3. Life expectancy ≥3 months. 4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available. 5. Subject must have at least one measurable lesion according to RECIST Version1.1. 6. Adequate organ function. Exclusion Criteria: 1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast. 2. Receipt of any anti-TIGIT, anti-TGF-β treatment. 3. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids. 4. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities). 5. Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery. 6. History of organ transplant. 7. Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.
References
Publications (0)
Data not yet available
No reference posted for this study.