Clinical trial · Interventional
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A decision was made to terminate the study due to the changing treatment landscape for the development of new agents in combination in Hodgkin lymphoma.
Summary
Brief summary (as posted)
A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adult Hodgkin's Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB040093 | Drug | — | UNRESOLVED |
| INCB040093 Monotherapy | Drug | — | UNRESOLVED |
| itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INCB040093 Monotherapy
- description
- INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
- interventionNames
- Drug: INCB040093 Monotherapy
- type
- EXPERIMENTAL
- label
- INCB040093 and itacitinib (INCB039110) Combination Therapy
- description
- Subjects allocated to Group B will be given INCB040093 BID in combination with itacitinib SR tablets. The dose of itacitinib will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.
- interventionNames
- Drug: INCB040093
- Drug: itacitinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, aged 18 years or older * Histologically confirmed diagnosis of classical HL * Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens * Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin * Eastern Cooperative Oncology Group (ECOG) 0 to 2 Exclusion Criteria: * Laboratory parameters not within the protocol-defined range * Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug. * Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent). * Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy * Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug * History of lymphoma involving the central nervous system * Evidence of active or prior hepatitis infection.
References
Publications (0)
Data not yet available