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RecruitingLast updated:8 September 2023

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.

Treatment Type

Radiotherapy,Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18+

Phase

I

More information

Trial Identifiers

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Commercial 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

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

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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