Clinical trial · Interventional
Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
NCT02675439CI-TRIAL-00055730terminatedPhase 1ClinicalTrials.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): No substantial anti-tumor activity was observed.
Summary
Brief summary (as posted)
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.
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/Metastatic Solid Tumors or Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADU-S100 | Drug | — | UNRESOLVED |
| ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation monotherapy
- description
- ADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms
- interventionNames
- Drug: ADU-S100
- type
- EXPERIMENTAL
- label
- Dose escalation combination
- description
- ADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued
- interventionNames
- Drug: ADU-S100
- Biological: ipilimumab
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* ECOG ≤ 1
* Willing to undergo tumor biopsies from injected and distal lesions
* Must have two biopsy accessible lesions:
* \* one lesion must be ≥10 mm and \<100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.
* a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
* tumors encasing major vascular structures (i.e., carotid artery or tumors close to other vital organs), are not considered appropriate
Exclusion Criteria:
* Patients who require local palliative measures such as XRT or surgery
* Symptomatic or untreated leptomeningeal disease.
* Presence of symptomatic central nervous system (CNS) metastases
* Impaired cardiac function or clinically significant cardiac disease
* Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
* Active infection requiring systemic antibiotic therapy.
* Known history of Human Immunodeficiency Virus (HIV) infection.
* Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Malignant disease, other than that being treated in this study.References
Publications (1)
- DERIVEDGogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453. PMID 32823563