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 being studied for the treatment of advanced or metastatic solid tumors and advanced non-small cell lung cancer. It is being evaluated in clinical trials for these oncology indications, with studies including patients with lung cancer, breast cancer, head and neck squamous cell carcinoma, endometrial cancer, melanoma, colorectal cancer, urothelial carcinoma, and cholangiocarcinoma.
NC318 is being developed by NextCure, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol NXTC. NextCure is conducting clinical trials to evaluate the safety and efficacy of NC318 in patients with advanced or metastatic solid tumors and advanced non-small cell lung cancer.
NC318 is currently in Phase 2 clinical development. A Phase 2 study is evaluating NC318 alone or in combination with pembrolizumab in patients with advanced non-small cell lung cancer. The drug is investigational and has not been approved by regulatory authorities. An earlier Phase 1 study has been completed.
NC318 has been studied in two clinical trials. NCT03665285 was a completed Phase 1 safety and tolerability study in advanced or metastatic solid tumors with 109 participants. NCT04699123 is an active Phase 2 study of NC318 alone or in combination with pembrolizumab in advanced non-small cell lung cancer, with 159 participants enrolled.
Yes, NC318 800 mg refers to the same drug, NC318, at a specific dose level. The 800 mg designation indicates the dose being evaluated in clinical studies. The drug is being developed by NextCure, Inc. for the treatment of advanced or metastatic solid tumors and advanced non-small cell lung cancer.