Clinical trial · Interventional
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial
Rollover Study to Continue IMSA101 Treatments in Patients With Advanced Treatment-Refractory Malignancies Previously Enrolled in the Phase I/IIA Safety and Efficacy Study of IMSA101
NCT06026254CI-TRIAL-00082633active not recruitingPhase 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)
This is a rollover study from parent protocol IMSA101-101 for adult patients with advanced malignancies that were previously receiving IMSA101 and who would continue to receive benefit with study treatment of IMSA101 in combination with an immune checkpoint inhibitor (ICI).
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 |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Checkpoint Inhibitor | Drug | Immune Checkpoint Inhibitor | ALIAS |
| IMSA101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- IMSA101 + ICI
- interventionNames
- Drug: IMSA101
- Drug: Immune Checkpoint Inhibitor
Primary outcomes (2)
- measure
- Drug-related safety
- timeFrame
- 12 months
- description
- Frequency of drug-related SAE by subject
- measure
- Anti-tumor effects
- timeFrame
- 12 months
- description
- Tumor response based on RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent and mental capability to understand the informed consent 2. Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment 3. Deriving clinical benefit from study treatment, as determined by the investigator 4. Must have fulfilled all required assessments in parent protocol IMSA101-101 5. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study Exclusion Criteria: 1. Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study 2. Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.