Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06947928 | Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma | PHASE2 | RECRUITING | 118 | — | — | Dec 11, 2025 | Dec 30, 2032 | Apr 17, 2026 | 18 | United States |
| NCT06940440 | IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC) | PHASE1 | RECRUITING | 9 | — | — | Oct 1, 2025 | May 31, 2028 | Oct 15, 2025 | 2 | United States |
ORR defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) at 12 weeks and confirmed on a second response assessment at least 28 days after the initial response assessment, in the treatment arm based on BICR assessment according to RECIST v1.1. Confirmed response persisting at the time of response assessment, at approximately 24 weeks will constitute the data utilized for the endpoint analysis.
Safety is defined as the absence of any grade 3-5, treatment-related Adverse Events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from first injection Day 1 to 28-day follow-up after the final dose of IFx-Hu2.0.
Feasibility is defined as the ability to treat ≥50% of subjects (i.e. 5/9) in the per-protocol analysis.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Participants randomized to the treatment arm will receive IFx-Hu2.0 (0.1 mg) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered intravenously (IV) on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the pembrolizumab dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until progressive disease (PD), unacceptable immune-related toxicities, or for a maximum duration of 2 years. |
| Control Arm | PLACEBO_COMPARATOR | Participants randomized to the control arm will receive placebo (0.9% Sodium Chloride Injection, USP) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered IV on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until PD, unacceptable immune-related toxicities, or for a maximum duration of 2 years. |
| IFx-Hu2.0 | EXPERIMENTAL | Subjects will receive IFx-Hu2.0 (0.1 mg) as a visceral lesion injection in a single lesion once per week for three consecutive weeks. KEYTRUDA® (pembrolizumab) (200 mg) will be administered intravenously (IV) on Visit 1 (within 48 hours from the first IFx-Hu2.0 injection) then every three weeks for approximately six months, until disease progression or unacceptable immune related toxicity. |
| Name | Type | Description |
|---|---|---|
| IFx-Hu2.0 | DRUG | Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional |
| Placebo | DRUG | Route of Administration: • Intralesional |
| Pembrolizumab | DRUG | Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion |
Inclusion Criteria: 1. At least 18 years of age. 2. Life expectancy equal to or greater than six months. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2. 4. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and h...