Phase 2
Completed N=40
Safety and Efficacy Study of IMSA101 in Refractory Malignancies
Solid Tumor, Adult
Source: ClinicalTrials.gov NCT04020185 ↗
Enrolled (actual)
40
Serious AEs
50.0%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities — 0; 0; 0; 0 Participants
Summary
Open-label, dose escalation (Phase I) and dose expansion (Phase IIA) study of patients receiving intra-tumoral IMSA101 alone or in combination with an immune checkpoint inhibitor (ICI) (Phase I and II)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Best Overall Response |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent and mental capability to understand the informed consent
- Male or female patients > 18 years of age
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancies refractory to or otherwise ineligible for treatment with standard-of-care agents/regimens, including but not limited to:
- Malignant melanoma
- Hormone receptor negative breast cancer
- Gastro-esophageal cancer
- Non-small cell lung cancer
- Head and neck cancer
- Hepatoma
- Renal cell carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Evaluable or measurable disease as follows:
- A minimum of 3 RECIST-evaluable lesions: one that is suitable for injection and biopsied; one non-injected that will be biopsied for abscopal effect; and one measurable lesion that will be followed for response only.
- Injectable tumors shall be accessed by intralesional (cutaneous) or percutaneous injection only, including those lesions that are visible, palpable, or detectable by standard radiographic or ultrasound methods. Neither surgical procedures nor endoscopically-guided injections including those to endobronchial, endoluminal, or endosinusial spaces shall be allowed. While no anatomic locations are required or disallowed, lesions selected for intratumoral injection must, in the opinion of the investigator:
- Not be immediately adjacent to blood vasculature or other physiologic landmarks in such a way that will accrue undue safety risk to the patient
- Have longest diameter ≥ 10 mm and ≤ 50 mm
- Be fully efficacy evaluable per RECIST v1.1 criteria
- Life expectancy > 3 months (Phase I) and > 6 months (Phase IIA)
- ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator
- Acceptable organ and marrow function as defined below:
- Absolute neutrophil count > 1,500 cells/μL
- Platelets > 50,000 cells/μL
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 2.5 times ULN. If liver metastases are present, AST/ALT 470)
- Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in opinion of the investigator would limit compliance with study requirements
- Women who are pregnant or breastfeeding
- Phase I combination only: Prior tumor progression through PD-1 or PD-L1 targeted ICI therapy.
Data sourced from ClinicalTrials.gov (NCT04020185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.