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Kinase Inhibitor

Emavusertib (+ Venetoclax) for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Curis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- R/R AML with spliceosome mutations of SF3B1 or U2AF1
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new leukemia drug, emavusertib, given alone or with azacitidine or venetoclax, to see if it is safe and effective in people with acute myelogenous leukemia or high-risk myelodysplastic syndrome.

Who is the study for?
Adults with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) who have had ≤2 prior cancer treatments can join this trial. They must be able to take oral medication, not be pregnant, agree to use contraception, and have a life expectancy of at least 3 months. People with CNS leukemia, recent anti-cancer treatments, unresolved toxicity from past therapies, certain infections like HIV or hepatitis B/C, severe heart disease or other serious health issues cannot participate.Check my eligibility
What is being tested?
The study is testing emavusertib as a single agent in patients with AML/MDS. It's an open-label Phase 1/2a trial where the dose will be increased gradually to find the safest and most effective level for treatment expansion. Previously there was a combination therapy part with venetoclax which is no longer accepting participants.See study design
What are the potential side effects?
Potential side effects of emavusertib may include digestive disturbances since it's taken orally; however specific side effects are not listed here but generally could involve typical reactions seen in cancer therapies such as fatigue, nausea, blood count changes and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML has specific genetic changes in SF3B1 or U2AF1.
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I am fully active or can carry out light work.
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I have high-risk MDS and can't undergo intensive chemotherapy.
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My MDS has specific genetic changes and I can't have strong chemotherapy.
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I cannot undergo intensive chemotherapy.
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I am a patient seeking treatment.
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I have AML and standard treatments have not worked for me.
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I have relapsed/refractory AML or high-risk MDS after first-line therapy.
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I can have repeated bone marrow and blood tests.
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My condition is high-risk myelodysplastic syndrome according to IPSS-R.
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My high-risk MDS did not respond to 2-3 cycles of treatment.
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My diagnosis of MDS or AML is confirmed through cell analysis.
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My AML or MDS has returned or didn't respond after the first treatment.
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I can swallow and keep down pills.
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My AML has relapsed or is resistant and has FLT3 mutations, including previous FLT3 inhibitor treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine Maximum Tolerated Dose (MTD) of emavusertib (CA-4948) monotherapy (Phase 1)
Determine Maximum Tolerated Dose (MTD) of emavusertib in combination with venetoclax (Phase 1b)
Determine the Recommended Phase 2 Dose (RP2D) of emavusertib in combination with venetoclax (Phase 1b)
+4 more
Secondary outcome measures
To assess clinical response (Phase 1 and 1b)
To assess clinical response (Phase 2a)
To assess tolerability and long term safety (Phase 2a)
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Emavusertib monotherapy dose expansionExperimental Treatment1 Intervention
The Expansion phase will begin once the RP2D from Phase 1 Dose Escalation phase has been identified. There will be 3 Cohorts and patients will be assigned to each Cohort based on baseline disease.
Group II: Emavusertib dose escalation + VenetoclaxExperimental Treatment2 Interventions
The starting dose for emavusertib will be 200 mg BID for 21 days of a 28-day Cycle. Anticipated emavusertib doses will be 200 and 300 mg BID. Venetoclax will be administered at 100 mg orally (Day 1) per the product label at the same time each day with a ramp up over 3 days to 400 mg for 21days of a 28-day Cycle. Second and subsequent cycles start with target dose level. This arm of the study has been closed to enrollment.
Group III: Emavusertib (CA-4948) dose escalationExperimental Treatment1 Intervention
Patients receive emavusertib monotherapy BID daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Curis, Inc.Lead Sponsor
16 Previous Clinical Trials
748 Total Patients Enrolled

Media Library

CA-4948 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04278768 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Emavusertib (CA-4948) dose escalation, Emavusertib dose escalation + Venetoclax, Emavusertib monotherapy dose expansion
Acute Myeloid Leukemia Clinical Trial 2023: CA-4948 Highlights & Side Effects. Trial Name: NCT04278768 — Phase 1 & 2
CA-4948 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278768 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the sample group for this medical trial?

"Yes, the information posted on clinicaltrials.gov states that this medical trial is in search of 325 participants from 2 sites and has been running since July 6th 2020, with its latest edit taking place on October 14th 2022."

Answered by AI

Which medical conditions is Emavusertib typically used to treat?

"For induction chemotherapy, Emavusertib is frequently used. This medication can also be beneficial for managing refractory anemias, leukemia, myelocytic acute and multilineage dysplasia."

Answered by AI

Are there any possibilities for participation in this medical experiment presently?

"Affirmative. Clinicaltrials.gov reveals that this trial, first posted on July 6th 2020, is actively recruiting participants. From two sites combined, 325 patients are required for enrolment in the study."

Answered by AI

What is the desired outcome of this medical experiment?

"Over the course of 24 months, this clinical trial seeks to determine overall response rate (Phase 2a - hrMDS patients) as its primary outcome. Secondary objectives include evaluating tolerance and long-term safety (Phase 2a), measuring clinical responses through assessing overall survival (OS) for Phase 1 and 1b, and monitoring any adverse effects that arise during the study."

Answered by AI

Are there any prior experiments that have been conducted with Emavusertib?

"At this juncture, 340 studies are underway to investigate the efficacy of Emavusertib. Of those trials, 54 have reached Phase 3 and there are 11189 different medical centres that offer these clinical trials across Edmonton, Alberta."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With AML or MDS
2020. "Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278768.
~124 spots leftby Apr 2026
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