Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NC318 · 2 trials · 10 indications
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 in arm 1a
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
The number of participants who have had at least one TEAE during the study.
| Arm | Type | Description |
|---|---|---|
| Arm 1a - NC318 only | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1a will receive NC318 alone. |
| Arm 1b - NC318 and Pembrolizumab | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. |
| Arm 1c - NC318 and Pembrolizumab | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. |
| Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab | EXPERIMENTAL | Arm 2 will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive therapy with NC318 in combination with pembrolizumab. |
| Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab | EXPERIMENTAL | Arm 2a will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive combination therapy with NC318 and pembrolizumab. |
| NC318 8mg | EXPERIMENTAL | Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 24mg | EXPERIMENTAL | Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 80mg | EXPERIMENTAL | Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 240mg | EXPERIMENTAL | Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 400mg | EXPERIMENTAL | Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 800mg | EXPERIMENTAL | Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 1600mg | EXPERIMENTAL | Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| Dose Expansion: 400mg Q2W | EXPERIMENTAL | Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| Dose Expansion: 800mg QW | EXPERIMENTAL | Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| Name | Type | Description |
|---|---|---|
| NC318 800 mg | DRUG | NC318 will be given intravenously (IV) weekly for 8 doses and then every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy. |
| NC318 400 mg | DRUG | NC318 will be given intravenously (IV) every 2 weeks. |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg will be given IV every 3 weeks |
| NC318 | DRUG | NC318 is an experimental antibody drug that may make the immune response more active against cancer. |
Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system) * ECOG performance status of 0 to 1 * Measurable di...
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NC318 is an investigational small molecule immunotherapy being developed by NextCure, Inc. for advanced solid tumors. It is in Phase 2 clinical development for advanced non-small cell lung cancer and has also been studied in a completed Phase 1 trial in advanced or metastatic solid tumors. NC318 is not approved for any indication.
NC318 is being studied for advanced non-small cell lung cancer, where it is tested alone or in combination with pembrolizumab. It was also evaluated in a completed Phase 1 study across advanced or metastatic solid tumors, including lung, breast, head and neck, endometrial, melanoma, colorectal, urothelial, and cholangiocarcinoma cancers.
NC318 is developed by NextCure, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker NXTC. NextCure is the sponsor of the clinical program evaluating NC318 in advanced non-small cell lung cancer and previously in advanced or metastatic solid tumors.
NC318 is in Phase 2 clinical development. The ongoing Phase 2 trial, NCT04699123, is active but not recruiting and is testing NC318 alone or with pembrolizumab in advanced non-small cell lung cancer. A separate Phase 1 safety and tolerability study, NCT03665285, has been completed.
NC318 has been studied in two registered trials. NCT04699123 is a Phase 2 study of NC318 alone or in combination with pembrolizumab in advanced non-small cell lung cancer, with 159 patients enrolled in the United States. NCT03665285 is a completed Phase 1 safety and tolerability study in advanced or metastatic solid tumors that enrolled 109 patients.