Phase 2
Completed N=110
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
Source: ClinicalTrials.gov NCT03058289 ↗Enrolled (actual)
110
Serious AEs
7.1%
Results posted
Aug 2024
Primary outcomePrimary: Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) — 0; 0; 1; 2 Participants
Summary
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also tested INT230-6 in combination with anti-PD-1 and anti-CTLA-4 antibodies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) |
0; 0; 1; 2; 4; 0 | — |
| SECONDARY Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria, |
83.3; 50.0; 64.3; 83.3 | — |
| SECONDARY Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6. |
34.27; 74.93; 1.35; 77.81; 113.7; .73 | — |
| SECONDARY Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6. |
6.38; 0; .33; 33.78; 59.94; .08 | — |
| SECONDARY Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6. |
77.98; 130.4; 106.3; 18.82; 78.73; 7.33 | — |
Eligibility Criteria
Inclusion Criteria
INT230-6 monotherapy Cohorts EC2 and EC3, combination with KEYTRUDA® cohort DEC2 and combination with Yervoy cohort FEC. Where criteria diverge the DEC2 and FEC specific criteria will be noted.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Men and Women > 18 years of age on the day of signing consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 50 ml/min; (for pembrolizumab combination please see supplements DEC/DEC2 for creatine criteria).
- ALT (SGOT)/AST (SGPT) ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases.
- Bilirubin ≤2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin 15 cm (in longest diameter). Treatment plan for subjects with tumors that are 9 to15 cm must be discussed with and approved by the medical monitor.
- Underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events.
- Concurrent medical condition requiring the use of immunosuppressive medications, or systemic corticosteroids (topical steroids are permitted); systemic corticosteroids must be discontinued at least 4 weeks prior to dosing. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the subject is on a stable dose. Non-absorbed intra-articular steroid injections will be permitted; or use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to study drug administration. Use of steroids as prophylactic treatment for subjects with contrast allergies to diagnostic imaging contrast dyes will be permitted.
- For deep tumor cohorts, subjects who require uninterrupted anticoagulants of any type, on daily aspirin therapy or NSAIAs.
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days prior to study drug administration.
Pregnancy Exclusion:
A WOCBP who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
NOTE: DEC or FEC combination cohorts have additional Exclusion criteria. Refer to the Investigative site for details.
Data sourced from ClinicalTrials.gov (NCT03058289). 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.