UPCC 04425 An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 As Monotherapy and in Combination in Patients With Advanced Haematological Malignancies

Investigational Study on a Treatment for Advanced Blood Cancers

Enrolling By Invitation
18 years or above
All
Phase 1/2
250 participants needed
1 Location

Brief description of study

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Detailed description of study

This includes patients with Peripheral T-cell lymphoma.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Provision of consent
  • ECOG performance status 0-2
  • Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
  • Must have previously received standard therapy
  • Adequate organ function

Exclusion Criteria:

  • Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  • Patients should discontinue statins prior to starting study treatment
  • CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
  • Any evidence of severe or uncontrolled systemic diseases
  • Any known uncontrolled inter-current illness
  • QTcF prolongation (> 470 msec)

This study investigates the safety and effectiveness of an investigational medication in patients with advanced blood cancers, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, and high-risk Myelodysplastic Syndrome.

Participants in the study will receive the investigational medication either alone or in combination with other treatments. The study will monitor the safety and biological effects of the medication, as well as how the body processes it, which is known as pharmacokinetics (PK).

  • Who can participate: Adults with relapsed or refractory Non-Hodgkin Lymphoma, Multiple Myeloma, or Acute Myeloid Leukemia who have already received standard therapy can participate. They must have a good performance status and adequate organ function.
  • Study details: Participants will be required to take the investigational medication and undergo regular health assessments to monitor their response and any side effects. The study will not involve any placebo; all participants will receive the active treatment.
Updated on 24 Jun 2026. Study ID: 25-0200
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator