Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CPI-818
Soquelitinib · 5 trials · 13 indications
Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
| Arm | Type | Description |
|---|---|---|
| Soquelitinib | EXPERIMENTAL | Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years |
| Standard of Care | ACTIVE_COMPARATOR | Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years |
| Cohort 1 - Soquelitinib 200 mg once daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Cohort 2 - Soquelitinib 200 mg twice daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Cohort 3 - Soquelitinib 400 mg once daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets will be taken orally twice daily for 12 weeks. |
| Single-Arm | OTHER | Participants receive open-label single arm of active tablets orally twice daily for 84 days. |
| Soquelitinib Dose Escalation and Dose Expansion | EXPERIMENTAL | In Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days. In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days |
| CPI-818 Dose Escalation | EXPERIMENTAL | Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for \>2 months or if dose determined to be unsafe. |
| CPI-818 Dose Expansion phase | EXPERIMENTAL | Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study. CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for \> 2 months. |
| Name | Type | Description |
|---|---|---|
| Soquelitinib | DRUG | Soquelitinib 200 mg tablets will be taken by mouth two times a day |
| Belinostat | DRUG | Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle |
| Pralatrexate | DRUG | Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle |
| Placebo | DRUG | Soquelitinib matching placebo tablets |
| CPI-818 | DRUG | Interleukin-2 inducible T-cell Kinase Inhibitor |
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymph...
Soquelitinib is an investigational small molecule drug developed by Corvus Pharmaceuticals, Inc. (ticker CRVS). It is being studied in atopic dermatitis, hidradenitis suppurativa, and T-cell lymphomas, including peripheral T-cell lymphoma not otherwise specified. It is also known as CPI-818.
Soquelitinib is being studied for atopic dermatitis, hidradenitis suppurativa, and T-cell lymphomas such as peripheral T-cell lymphoma not otherwise specified. It is an investigational therapy and is not approved for any indication. Clinical development spans dermatology and oncology settings.
Soquelitinib targets ITK, an interleukin-2 inducible T-cell kinase. It belongs to the -tinib kinase inhibitor class. By inhibiting ITK, the drug is designed to modulate T-cell signaling, which is relevant to both inflammatory skin conditions and T-cell lymphomas.
Soquelitinib is developed by Corvus Pharmaceuticals, Inc., which trades under the ticker CRVS. The company is also the sponsor of the clinical trials evaluating the drug in atopic dermatitis, hidradenitis suppurativa, and T-cell lymphoma.
Soquelitinib is in Phase 2 development overall, with a Phase 3 trial also recruiting in relapsed or refractory peripheral T-cell lymphoma. It is investigational and has not been approved by the FDA. Trials include Phase 1 and Phase 2 studies in atopic dermatitis and a Phase 1 study in hidradenitis suppurativa.
Soquelitinib trials include NCT07441395, a Phase 2 study in moderate to severe atopic dermatitis, and NCT07828860, a Phase 1 study in hidradenitis suppurativa, both recruiting. NCT06561048 is a Phase 3 trial in relapsed or refractory peripheral T-cell lymphoma. NCT06345404, a Phase 1 atopic dermatitis study, is completed.
Yes, soquelitinib is also known as CPI-818. Both names refer to the same investigational small molecule developed by Corvus Pharmaceuticals, Inc. (CRVS). Searches for CPI-818 and soquelitinib refer to the same ITK inhibitor being studied in dermatology and T-cell lymphoma.