CompletedPhase 1

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

United States232 participantsStarted 2019-02-11

Plain-language summary

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies * Biomarker-selected solid tumors * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 * Adequate organ function (bone marrow, hepatic, renal, cardiovascular) * Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial Exclusion Criteria: * Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases * Requirement of pharmacologic doses of glucocorticoids * Prior treatment with chimeric antigen receptor T cells (CAR-T cells) * HIV positive; known active hepatitis B or C * Known hypersensitivity to any of the components of PRT543 * Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation

What they're measuring

To describe dose limiting toxicities (DLT) of PRT543

Timeframe: Baseline through Day 28.

To determine the maximally tolerated dose (MTD)

Timeframe: Baseline through approximately 2 years.

To determine the recommended phase 2 dose (RP2D) and schedule of PRT543

Timeframe: Baseline through approximately 2 years.

Trial details

NCT IDNCT03886831

SponsorPrelude Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-16

View on ClinicalTrials.gov More Relapsed/Refractory Advanced Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To describe dose limiting toxicities (DLT) of PRT543

Timeframe: Baseline through Day 28.

To determine the maximally tolerated dose (MTD)

Timeframe: Baseline through approximately 2 years.

To determine the recommended phase 2 dose (RP2D) and schedule of PRT543

Timeframe: Baseline through approximately 2 years.