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Also known as INBRX-106 - Hexavalent OX40 agonist antibody
INBRX-106- Hexavalent OX40 agonist antibody · 1 trial · 8 indications
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Major pathological response (mPR) and pathological complete response (cPR) criteria.
| Arm | Type | Description |
|---|---|---|
| Part 1 INBRX-106 Escalation (Not Recruiting) | EXPERIMENTAL | INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors. |
| Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting) | EXPERIMENTAL | INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors. |
| Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting) | EXPERIMENTAL | Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 |
| Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting) | EXPERIMENTAL | Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 |
| Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | EXPERIMENTAL | Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts. |
| Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | EXPERIMENTAL | Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts. |
| Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting) | ACTIVE_COMPARATOR | Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. |
| Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting) | EXPERIMENTAL | Subjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg/kg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. |
| Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting) | EXPERIMENTAL | Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks. |
| Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting | EXPERIMENTAL | Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks |
| Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting) | EXPERIMENTAL | Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks |
| Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC | EXPERIMENTAL | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks |
| Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC | EXPERIMENTAL | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks |
| Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC | EXPERIMENTAL | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given |
| Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC | EXPERIMENTAL | Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles. |
| Name | Type | Description |
|---|---|---|
| INBRX-106 - Hexavalent OX40 agonist antibody | DRUG | The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4). |
| pembrolizumab 200 mg | DRUG | pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle. |
| pembrolizumab 400 mg | DRUG | pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks) |
| Carboplatin AUC-5 | DRUG | carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4. |
| Carboplatin AUC-6 | DRUG | carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 |
| Pemetrexed 500 mg/m2 | DRUG | pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4. |
| Cisplatin 75mg/m2 | DRUG | cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 |
| Paclitaxel 200mg/m2 | DRUG | paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 |
| Nab paclitaxel 100mg/m2 | DRUG | Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4 |
| Gemcitabine (1000 mg/m2) | DRUG | Gemcitabine 1000 mg/m2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4 |
Select Inclusion Criteria: * Males or females aged ≥18 years. * Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INBRX-106 is an investigational hexavalent OX40 agonist antibody being studied for the treatment of locally advanced or metastatic solid tumors, including non-small cell lung cancer, head and neck cancer, melanoma, gastric cancer, renal cell carcinoma, and urothelial carcinoma. It is currently in Phase 1 clinical development.
INBRX-106 targets OX40, a costimulatory receptor on T cells. As a hexavalent OX40 agonist antibody, it is designed to activate OX40 signaling, which may enhance the immune system's anti-tumor response. This mechanism is being evaluated in the context of solid tumor immunotherapy.
INBRX-106 is being developed by Inhibrx Biosciences, Inc., a biopharmaceutical company traded under the ticker symbol INBX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational OX40 agonist antibody in patients with solid tumors.
INBRX-106 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in solid tumor indications.
INBRX-106 is being studied in a Phase 1 clinical trial with the identifier NCT04198766. This trial evaluates INBRX-106 alone and in combination with pembrolizumab (Keytruda) in subjects with locally advanced or metastatic solid tumors. The trial is recruiting participants in the United States, Singapore, South Korea, and Taiwan.
Yes, INBRX-106 and INBRX-106 - Hexavalent OX40 agonist antibody refer to the same investigational drug. The full name describes its structure as a hexavalent antibody targeting OX40. In clinical trial registries and scientific literature, it may be listed under either name.