Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nogapendekin alfa inbakicept · 3 trials · 10 indications
Progression-free survival (PFS) as assessed by RECIST 1.1 criteria comparing the experimental treatment arm with the standard-of-care control arm in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).
Proportion of participants who die from any cause within 28 days of randomization
Number of participants experiencing ≥1 treatment-emergent adverse event (TEAE) and ≥1 serious adverse event (SAE), graded per NCI CTCAE v5.0. Adverse events will be coded using MedDRA. Analyses will be performed in the safety population (all participants receiving ≥1 dose of study treatment).
Number and percent of participants with protocol-defined clinically important laboratory abnormalities (hematology, chemistry including liver/renal, coagulation) or vital-sign changes that meet action criteria or result in dose modification, treatment interruption, or discontinuation; summarized by grade and action taken.
| Arm | Type | Description |
|---|---|---|
| Phase 2a, Single Arm (Safety Lead-In) | EXPERIMENTAL | Participants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042 during the Phase 2a safety lead-in portion of the study. |
| Arm A | EXPERIMENTAL | Participants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042. |
| Arm B | ACTIVE_COMPARATOR | Participants will receive standard-of-care intensity-modulated radiation therapy (IMRT) with concurrent cisplatin for locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). |
| NAI + Standard of Care | EXPERIMENTAL | NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC \<700 cells/µL), Day 14, and Day 21 if needed for ALC \<1,000 cells/µL, plus institutional standard of care for sepsis |
| Standard of Care Alone | ACTIVE_COMPARATOR | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated |
| Neoadjuvant NAI + sotevtamab + zabadinostat + gemcitabine/nab-paclitaxel; adjuvant NAI | EXPERIMENTAL | Participants receive neoadjuvant therapy of nogapendekin alfa inbakicept (NAI) SC + sotevtamab IV + oral zabadinostat plus gemcitabine and nab-paclitaxel IV for up to 6 × 28-day cycles, with zabadinostat given Days 1-5 (second course Days 15-19 per SRC), sotevtamab/gemcitabine/nab-paclitaxel on Days 1, 8, 15, and NAI on Days 1 and 15 (weight-based ≤50 kg). After ≥2 cycles participants may be reassessed for surgical resection; resected participants receive adjuvant NAI SC on Days 1 and 15 of each 28-day cycle until recurrence, unacceptable toxicity, withdrawal, or investigator decision. Premedication and infusion-reaction management per protocol; safety follow-up per study schedule. |
| Name | Type | Description |
|---|---|---|
| Nogapendekin Alfa Inbakicept (NAI) | DRUG | NAI 1.2 mg administered subcutaneously as part of the experimental treatment regimen. |
| hAd5-HPV Vaccine (IBRX-042) | BIOLOGICAL | IBRX-042 administered subcutaneously as part of the experimental treatment regimen. |
| Nab-Paclitaxel | DRUG | Nab-paclitaxel 100 mg/m² administered intravenously during neoadjuvant treatment cycles. |
| Cisplatin | DRUG | Cisplatin 40 mg/m² administered intravenously concurrently with radiation therapy. |
| De-Intensified IMRT | RADIATION | IMRT 40 Gy, delivered once daily, 5 days/week, over 4 weeks (20 total fractions) |
| Standard of Care IMRT | RADIATION | SOC IMRT 70 Gy, delivered once daily, 5 days/week, over 7 weeks (35 total fractions) |
| Standard of Care (SOC) | OTHER | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated |
| Nogapendekin Alfa Inbakicept (N803) | DRUG | 1.2mg SC |
| Sotevtamab | DRUG | 800mg IV |
| Zabadinostat (CXD101) | DRUG | 10mg IV |
| Nab paclitaxel / gemcitabine | DRUG | Nab-Paclitaxel (125mg/m2 IV) and Gemcitabine (1,000 mg/m2 IV) |
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histolog...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |