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RecruitingLast updated: 2 February 2024

This study is evaluating how safe and tolerable a new targeted therapy is (called PRT2527) when given alone, and in combination with another targeted therapy (called zanubrutinib), in people with certain relapsed or refractory blood cancersA Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib in Participants With Relapsed/Refractory Hematologic Malignancies

Clinical summary

Summary

This study will be conducted in two parts: dose escalation and dose confirmation. The dose escalation phase will evaluate escalating doses of a new targeted therapy (called PRT2527) as monotherapy, and in combination with another targeted therapy (called zanubrutinib) until the maximum tolerated dose (MTD) has been identified or when the recommended phase 2 dose is determined (RR2D). The dose confirmation phase will evaluation cancer-specific cohorts at the recommended phase 2 dose level (RP2D) to confirm how safe, tolerable and effective that dose is. Eligible participants will be allocated to receive either PRT2527 alone, or in combination with zanubrutinib. PRT2527 will be administered by intravenous infusion (IV) and zanubrutinib will be provided in capsules to take orally once a day.

Conditions

This trial is treating patients with aggressive B-cell lymphoma subtypes, mantle cell lymphoma, chronic lymphocytic leukaemia, small lymphocytic lymphoma, including Richter's syndrome and T-cell lymphoma subtypes

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Prelude Therapeutics

Scientific Title

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib in Participants With Relapsed/Refractory Hematologic Malignancies

Eligibility

Inclusion

  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma subtypes, MCL, CLL/SLL, including Richter's syndrome, based on local testing , or TCL (monotherapy only) that have relapsed or become refractory to or be ineligible for standard-of-care therapy
  • Must provide either an archival or fresh tumor tissue sample from a core or excisional/surgical biopsy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function (hematology, renal, and hepatic)
  • Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%

Exclusion

  • Have active central nervous system involvement by malignancy, uncontrolled intercurrent illnesses, and active infections requiring systemic therapy
  • Have undergone HSCT within the last 90 days or have graft versus host disease (GvHD) Grade > 1 at study entry
  • Mean corrected QT interval of > 470 msec following triplicate ECG measurements or a history of long QT Syndrome
  • Have severe pulmonary disease with hypoxemia
  • History of another malignancy except for adequately treated non-melanoma skin cancer or lentigo maligna, superficial bladder cancer, and carcinoma in situ of the cervix without evidence of disease, and asymptomatic prostate cancer without known metastatic disease and no requirement for therapy
  • Concurrent treatment or within 15 days of starting study treatment with strong CYP3A4 inhibitors or inducers or use of moderate CYP3A4 inducers (for combination therapy only)
  • Prior exposure to a CDK9 inhibitor
  • Wait at least 5 half-lives of the agent or 14 days after their investigational or approved therapies before start of study treatment, whichever is shorter
  • Mean corrected QT interval of > 470 msec following triplicate ECG measurement or history of long QT syndrome
  • T-Cell leukemias

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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