Clinical trial · Interventional
Intratumoral CAN2109 in Subjects With Solid Tumors
A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.
NCT06332430CI-TRIAL-00083925recruitingPhase 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 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAN2109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAN2109
- description
- CAN2109 IT injection every three weeks (Q3W)
- interventionNames
- Drug: CAN2109
Primary outcomes (3)
- measure
- Safety
- timeFrame
- 12 months
- description
- determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
- measure
- Recommended Phase 2 Dose (RP2D)
- timeFrame
- 12 months
- description
- To determine a recommended phase 2 dose of CAN21909 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide written informed consent and willing to comply with the study's requirements. 2. Male or female age ≥ 18 years at screening. 3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy. Preferred tumor types include the following: a. Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer 4. Performance status of 0-1 on the ECOG Performance Scale. Exclusion Criteria: 1. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo. 2. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent. 3. Has an active infection requiring systemic therapy. 4. Unstable/inadequate cardiac function defined as follows: 1. New York Heart Association Class 3 or 4 congestive heart failure 2. uncontrolled hypertension 3. acute coronary syndrome within 6 months 4. clinical important cardiac arrhythmia 5. mean corrected QT (QTc) interval corrected for heart rate \> 480 ms. 5. A history of interstitial lung disease. 6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders. 7. Participated in a clinical study of an investigational agent within 30 days of screening. 8. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator. 9. Is pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.