Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CMP-001 · 3 trials · 3 indications
TEAEs will be evaluated and assigned a grade using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
TEAEs will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
TEAEs will be evaluated and assigned a grade using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
| Arm | Type | Description |
|---|---|---|
| Part A (CMP-001, Atezolizumab and Optional Radiation Therapy) | EXPERIMENTAL | Participants will receive CMP-001 5 milligrams (mg) SC once weekly for 2 weeks, then 10 mg IT once weekly for 3 weeks, followed by every 3 weeks thereafter until discontinuation of treatment in combination with atezolizumab SC every 3 weeks starting at Week 2. Route of administration (IT/SC) for CMP-001 beyond Week 5 will be determined by Investigator. Participants enrolled in Part A who progressed per RECIST v1.1 on combination of CMP-001 and atezolizumab have opportunity to enroll in Part A optional radiation therapy add-on after documented disease progression per CT/MRI or PET scan. After CMP-001 washout period of 10 days, participants will be treated with radiation consisting of 20 grays in 5 fractions for 5 days then resume CMP-001 treatment. |
| Part B (Radiation Therapy, CMP-001 and Atezolizumab) | EXPERIMENTAL | Participants will be treated with radiation therapy consisting of 20 grays in 5 fractions for 5 days, then participants will receive CMP-001 5 mg SC once weekly for 2 weeks, then 10 mg IT once weekly for 3 weeks, followed by dosing every 3 weeks thereafter until discontinuation of treatment. The route of administration (that is, IT or SC) for CMP-001 beyond Week 5 will be determined by the Investigator. First dose of CMP-001 will be administered within 2 days of radiation therapy. Atezolizumab will be administered SC in combination with CMP-001 every 3 weeks starting at Week 2. |
| Part 1: Dose-Escalation - CMP-001 (SC) and Pembrolizumab | EXPERIMENTAL | Participants will receive up to 7 escalating dose levels (5 milligrams \[mg\], 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, and 20 mg) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. |
| Part 1: Dose-Expansion - CMP-001 (SC) and Pembrolizumab | EXPERIMENTAL | Participants will receive RP2D (as determined in Part 1 dose-escalation phase) of CMP-001 via SC injection once a week for 3 weeks and every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. |
| Part 2: CMP-001 (SC and IT) and Pembrolizumab | EXPERIMENTAL | Participants will receive CMP-001 via SC injection once weekly for 2 weeks, then IT injection once weekly for 4 weeks, and SC injection once weekly for every 3 weeks thereafter until discontinuation of treatment in combination with pembrolizumab at its labelled dose and schedule. CMP-001 planned IT dose level in Part 2 will be up to 10 mg and the SC dose will be the RP2D determined from Part 1 dose-escalation phase of the study. |
| Part 1: Dose-Escalation - CMP-001 and Pembrolizumab | EXPERIMENTAL | Participants will receive up to 5 escalating dose levels (1 milligram \[mg\], 3 mg, 5 mg, 7.5 mg and 10 mg) of CMP-001 via intratumoral injection according to one of 2 schedules (Schedule A: once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued; Schedule B: once weekly for 2 weeks, followed by every 3 weeks thereafter until participant is discontinued) in combination with pembrolizumab at its labelled dose and schedule. |
| Part 1: Dose-Expansion - CMP-001 and Pembrolizumab | EXPERIMENTAL | Participants will receive CMP-001 10 mg via intratumoral injection by Schedule A (once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued) in combination with pembrolizumab at its labelled dose and schedule. As of 05 October 2018, the dose and schedule for Part 1 Dose Expansion Phase was selected based on all available safety, efficacy and pharmacodynamic data from the Part 1 Dose Escalation Phase. Participants who were enrolled prior to 05 October 2018 to receive CMP-001 doses less than (\<) 10 mg will have the option to receive CMP-001 doses up to 10 mg on Schedule A in combination with pembrolizumab. |
| Part 2: CMP-001 Monotherapy and Crossover to Combination | EXPERIMENTAL | Participants will receive CMP-001 10 mg via intratumoral injection by Schedule A (once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued). Participants who were enrolled prior to 05 October 2018 to receive CMP-001 doses \<10 mg will have the option to receive CMP-001 doses up to 10 mg on Schedule A. Participants with documented progression while on CMP-001 monotherapy treatment will have the option to crossover to the combination treatment of CMP-001 10 mg plus pembrolizumab, at the discretion of the Investigator. |
| Name | Type | Description |
|---|---|---|
| CMP-001 | DRUG | CMP-001 will be administered as per the dose and schedule specified in the respective arms. |
| Atezolizumab | DRUG | Atezolizumab will be administered as per the approved label and according to the schedule specified in the respective arms. |
| Radiation Therapy | RADIATION | Radiation therapy will be administered using either 3-dimensional (3D) conformal radiotherapy or intensity-modulated radiation therapy (IMRT) to non-target node or metastatic lesion as per the dose and schedule specified in the respective arms. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as per the schedule specified in the respective arms. |
Inclusion Criteria: * Histopathologically confirmed diagnosis of metastatic NSCLC. * Documented disease progression on prior programmed cell death-1/programmed death-ligand 1 (PD-1/PD-L1) therapy in any line. Participants must have received a minimum of 4 doses of anti-PD-1/PD-L1 therapy before enr...
CMP-001 is an investigational small molecule being studied for the treatment of malignant melanoma, non-small cell lung cancer, and melanoma. It is being developed by Regeneron Pharmaceuticals, Inc. (REGN). The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.
CMP-001 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. Regeneron is conducting clinical trials to evaluate the safety and efficacy of CMP-001 in oncology indications.
CMP-001 is in Phase 1 clinical development. It has completed three Phase 1 trials, including studies in melanoma and non-small cell lung cancer. The drug remains investigational and has not received FDA approval for any indication.
CMP-001 has been studied in three completed Phase 1 trials. NCT02680184 evaluated CMP-001 in combination with pembrolizumab or as monotherapy in melanoma. NCT03084640 studied alternative routes of administration with pembrolizumab in advanced melanoma. NCT03438318 evaluated CMP-001 with atezolizumab in non-small cell lung cancer.
CMP-001 is also known by its chemical name and is being developed under this identifier. No alternative brand names have been disclosed in the clinical trial data. It is distinct from other oncology drugs and is being studied as a monotherapy and in combination with checkpoint inhibitors.