A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04543305 |
Recruitment Status :
Recruiting
First Posted : September 10, 2020
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma Acute Myeloid Leukemia Non Hodgkin Lymphoma Myelodysplastic Syndromes | Drug: PRT1419 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies |
Actual Study Start Date : | September 28, 2020 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | September 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: PRT1419
PRT1419 will be administered orally
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Drug: PRT1419
PRT1419 will be administered orally |
- To describe dose limiting toxicities (DLT) of PRT1419 [ Time Frame: Baseline through Day 28 ]Dose limiting toxicities will be evaluated through the first cycle
- To determine the maximally tolerated dose (MTD) and/or optimal biological dose (OBD) [ Time Frame: Baseline through approximately 2 years ]The MTD and/or OBD will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome
- To determine the recommended phase 2 dose (RP2D) and schedule of PRT1419 [ Time Frame: Baseline through approximately 2 years ]The RP2D will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome
- To describe the adverse event profile and tolerability of PRT1419 [ Time Frame: Baseline through approximately 2 years ]Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
- To describe the pharmacokinetic profile of PRT1419 [ Time Frame: Baseline through approximately 2 years ]PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration
- To describe any anti-tumor activity of PRT1419 [ Time Frame: Baseline through approximately 2 years ]Anti-tumor activity of PRT1419 will be based on the measurement of objective responses

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
- Left ventricular ejection fraction of ≥50%
- Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial
- Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1)
- All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 14 days, whichever is longer before study entry
- AML patients only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification and patients with targeted mutations must have been treated with appropriate therapy for their disease
- MDS patients only: Intermediate, high, or very high risk by International Prognostic Scoring System-Revised [IPSS-R] criteria that is relapsed or refractory to approved therapies
- NHL patients only: Histologically or cytologically confirmed NHL, including B- and T-cell lymphomas that is relapsed or refractory or intolerant to approved therapies. Must have one lesion that can be measured for response
- MM patients only: Measurable disease defined by one or more of the following: Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours, Serum Free Light Chain (sFLC) > 10 mg/dL with normal serum FLC ratio. Presence of soft tissue plasmacytoma confirmed by imaging
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NHL and MM patients only: must have the following lab values within 14 days prior to study Day 1:
- ANC ≥1.0 x 10˄3 μL
- Platelet count ≥50,000 μL
Exclusion Criteria:
- Known hypersensitivity to any of the components of PRT1419
- Female patients who are pregnant or lactating
- Mean QTcF interval of >480 msec
- History of heart failure, additional risk factors for arryhthmias or requiring concomitant medications that prolong the QT/QTc interval
- Hematopoietic stem-cell transplant < 90 days or have GVHD Grade >1 at study entry
- Uncontrolled intercurrent illnesses
- Treatment with strong inhibitors of CYP2C8 and/or P-glycoprotein for which there are no therapeutic substitutions
- Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
- HIV positive; known active hepatitis B or C
- Prior exposure to an MCL1 inhibitor
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History of another malignancy except:
- Malignancy treated with curative intent with no known active disease for >2 years at study entry
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543305
Contact: Study Contact | 302-644-5434 | PRT1419-01Study@Preludetx.com |
United States, Colorado | |
Colorado Blood Cancer Institute | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Study Contact 302-644-5434 PRT1419-01Study@Preludetx.com | |
United States, Florida | |
Florida Cancer Specialists | Recruiting |
Lake Mary, Florida, United States, 32742 | |
Contact: Study Contact 302-644-5434 PRT1419-01Study@Preludetx.com | |
Florida Cancer Specialists | Recruiting |
Sarasota, Florida, United States, 34232 | |
Contact: Study Contact 302-644-5434 PRT1419-01Study@Preludetx.com | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Study Contact 302-644-5434 PRT1419-01Study@Preludetx.com |
Responsible Party: | Prelude Therapeutics |
ClinicalTrials.gov Identifier: | NCT04543305 |
Other Study ID Numbers: |
PRT1419-01 |
First Posted: | September 10, 2020 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Hematologic Neoplasms Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Neoplasms by Site |