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Also known as INBRX-106 - Hexavalent OX40 agonist antibody, Hexavalent OX40 agonist antibody
INBRX-106 · 3 trials · 10 indications
Patients achieving (\>30%) reduction in ultrasound estimate of breast mass volume (mL) at the end of 2 cycles investigational therapy
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).
OS is the time from randomization to death due to any cause
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 |
|---|---|---|
| Pembrolizumab + INBRX-106 | EXPERIMENTAL | Patients will be given pembrolizumab at a dose of 200mg IV in combination with INBRX-106 at a dose of 0.1mg/kg IV every 3 weeks. |
| INBRX-106 plus pembrolizumab | EXPERIMENTAL | Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3) |
| pembrolizumab monotherapy (+ placebo in phase 3 part) | ACTIVE_COMPARATOR | Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3) |
| 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 |
|---|---|---|
| Pembrolizumab | DRUG | Drug will be delivered per standard-of-care as established by trial Keynote-522. |
| INBRX-106 | DRUG | INBRX-106 is a hexavalent, recombinant humanized IgG1, OX40 agonist antibody that targets the human OX40 receptor (TNFRSF4, UniProtKB: P43489). INBRX-106 is based on a sdAb platform and, in detail, 3 identical humanized camelid heavy chain-only antibody binding domains (VHHs) targeting OX40 are joined end-to-end and with an Fc based on human IgG1 to create a molecule that homo-dimerizes into an antibody targeting a total of 6 OX40 receptors. |
| 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 |
Inclusion Criteria: 1. Age ≥ 18 years, inclusive of all genders. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2. 3. Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll ...
INBRX-106 is an investigational cancer therapy being studied in head and neck squamous cell carcinoma, triple negative breast cancer, and other solid tumors. It is being developed as a combination treatment with pembrolizumab. The program is in Phase 2 clinical development and has not been approved for any indication.
INBRX-106 targets OX40, a co-stimulatory receptor on T cells. It is a hexavalent OX40 agonist antibody designed to activate OX40 signaling and enhance T cell mediated antitumor immune responses. By clustering OX40 receptors, the hexavalent format aims to provide stronger immune activation than bivalent antibodies.
INBRX-106 is being developed by Inhibrx Biosciences, Inc., which trades on the Nasdaq under the ticker INBX. The company is running clinical trials of INBRX-106 both as a monotherapy and in combination with pembrolizumab (Keytruda) across multiple cancer types.
INBRX-106 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority. The Phase 2 program includes studies in triple negative breast cancer and head and neck squamous cell carcinoma, with a Phase 1 solid tumor study also ongoing.
INBRX-106 is being evaluated in three registered clinical trials. NCT06353997 is a Phase 2 neoadjuvant study in triple negative breast cancer. NCT06295731 is a Phase 2 study in first-line PD-L1 CPS at least 20 head and neck squamous cell carcinoma. NCT04198766 is a Phase 1 study in advanced solid tumors.
Yes, INBRX-106 is also known as the hexavalent OX40 agonist antibody. These names refer to the same investigational agent developed by Inhibrx Biosciences. The hexavalent description reflects its molecular format, an antibody engineered with six OX40 binding domains to cluster OX40 receptors and drive T cell activation.