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This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPI-818 | Drug | Interleukin-2 inducible T-cell Kinase Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose | First dose until 30 days after treatment stop | |
| Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818 | Up to approximately 21 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 | Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. | |
| Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suresh Mahabhashyam, MD, MPH | Corvus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| University of Michigan |
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| Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. |
| Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma | From start of treatment through end of study treatment, up to approximately 24 months |
| Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment. | Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. |
| Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment. | Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Epworth Healthcare | Melbourne | Victoria | 3002 | Australia |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100052 | China |
| Beijing Boren Hospital | Beijing | Beijing Municipality | 100142 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Shanghai East Hospital | Pudong | Shanghai Municipality | 200136 | China |
| Henan Cancer Hospital | Henan | Zhengzhou | 450003 | China |
| Seoul National University Hospital | Seoul | Gyeonggido | 03080 | South Korea |
| Asan Medical Center | Seoul | Gyeonggido | 05505 | South Korea |
| Samsung Medical Center | Seoul | Gyeonggido | 06351 | South Korea |
| Seoul St. Mary's Hospital | Seoul | Gyeonggido | 06591 | South Korea |
| Inje University Busan-Paik Hospital | Busan | 47392 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Gachon University | Incheon | 21565 | South Korea |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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