Clinical trial · Interventional
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
NCT05867420CI-TRIAL-00101727recruitingPhase 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)
The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid 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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASKG915 | Biological | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fruquintinib | Drug | Fruquintinib | ALIAS |
| Paclitaxel + Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ASKG915
- description
- For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC).
- interventionNames
- Biological: ASKG915
- type
- EXPERIMENTAL
- label
- ASKG915 combination with SOC
- description
- For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
- interventionNames
- Biological: ASKG915
- Drug: Paclitaxel + Bevacizumab
- Drug: Fruquintinib
- Drug: Docetaxel
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. 2. ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 3 months. 4. The results of the laboratory tests must meet all criteria. Exclusion Criteria: 1. Patients have received antitumor therapy during the first 4 weeks before study drug use. 2. Received a live attenuated vaccine within 4 weeks prior to C1D1. 3. Known cerebral parenchymal metastasis or meningeal metastasis. 4. History of serious cardiovascular or cerebrovascular diseases. 5. Active or recurrent autoimmune diseases. 6. History of ascites or pleural effusion requiring drainage. 7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.
References
Publications (0)
Data not yet available
No reference posted for this study.