← Back to Search

Bioavailable Inhibitor

HQP1351 for Leukemia

Phase 1
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is studying the side effects of HQP1351 in people with CML or Ph+ ALL who have resistance or intolerance to TKIs.

Who is the study for?
This trial is for people with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), who have not responded well to at least two tyrosine kinase inhibitors (TKIs). Participants must be able to follow the study procedures and agree to use effective contraception. Those with certain health conditions, recent surgeries, active infections like HIV or hepatitis, poorly controlled diabetes, or a history of other cancers within the last year are excluded.Check my eligibility
What is being tested?
The trial is testing HQP1351, a new drug for patients resistant to standard treatments for CML and Ph+ ALL. It's an open-label study where everyone knows what treatment they're getting. The goal is to find out how much of the drug can be safely given (the recommended phase 2 dose) and understand how it affects the body by studying its pharmacokinetics.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored closely for any adverse reactions due to HQP1351. Common side effects from similar drugs include nausea, fatigue, muscle pain, rash, liver problems and changes in blood counts that could increase infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) of HQP1351
Maximum Plasma Concentration (Cmax) of HQP1351

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
52%
Stomatitis
46%
Anaemia
25%
Neutropenia
21%
Thrombocytopenia
21%
Abdominal pain
21%
Vomiting
19%
Pyrexia
17%
Nausea
17%
Febrile neutropenia
17%
Diarrhoea
15%
Platelet count decreased
15%
Headache
13%
Constipation
13%
Epistaxis
13%
Alanine aminotransferase increased
10%
Rash
10%
Back pain
10%
Rhinitis
10%
Hypokalaemia
10%
Pain in extremity
10%
Pruritus
10%
Aspartate aminotransferase increased
8%
Abdominal pain upper
8%
Mucosal inflammation
8%
Hypertension
8%
Hypotension
8%
Arthralgia
8%
Aplasia
8%
Hypertransaminasaemia
6%
Leukopenia
6%
Oral pain
6%
Oropharyngeal pain
6%
Haematoma
6%
Pain
6%
Hepatotoxicity
6%
Fluid balance positive
6%
Antithrombin III decreased
4%
Erythema
4%
Hypogammaglobulinaemia
4%
Anal inflammation
4%
Fatigue
4%
Neutrophil count decreased
2%
Bronchitis
2%
Clostridium difficile colitis
2%
Lipase increased
2%
Pancreatitis acute
2%
Device related infection
2%
Vulvitis
2%
Decreased appetite
2%
Pneumothorax traumatic
2%
Capillary leak syndrome
2%
Petechiae
2%
Staphylococcal infection
2%
Viral infection
2%
B precursor type acute leukaemia
2%
Septic shock
2%
Nasopharyngitis
2%
Cough
2%
Acute lymphocytic leukaemia recurrent
2%
Escherichia bacteraemia
2%
White blood cell count decreased
2%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
HC3 Chemotherapy
Blinatumomab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort DExperimental Treatment2 Interventions
Group II: Cohort CExperimental Treatment1 Intervention
Group III: Cohort BExperimental Treatment1 Intervention
Group IV: Cohort AExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
45 Previous Clinical Trials
3,888 Total Patients Enrolled
8 Trials studying Leukemia
424 Patients Enrolled for Leukemia
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,244 Total Patients Enrolled
3 Trials studying Leukemia
180 Patients Enrolled for Leukemia

Media Library

HQP1351 (Bioavailable Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04260022 — Phase 1
Leukemia Research Study Groups: Cohort A, Cohort B, Cohort C, Cohort D
Leukemia Clinical Trial 2023: HQP1351 Highlights & Side Effects. Trial Name: NCT04260022 — Phase 1
HQP1351 (Bioavailable Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04260022 — Phase 1

Frequently Asked Questions

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

What is the current enrollment count for this experiment?

"In order to carry out this clinical trial, Ascentage Pharma Group Inc. needs a total of 62 participants that meet the necessary criteria. The sponsor will be managing the study through sites such as Fred Hutchinson Cancer Research Center in Seattle, Washington and University of Texas MD Anderson Cancer Center located in Houston,Texas."

Answered by AI

What risks are posed by the use of Blinatumomab for treatment?

"Due to limited data, we have assessed Blinatumomab's safety at a score of 1 out of 3. This is in accordance with the fact that this trial is still on its first phase and efficacy has yet to be fully established."

Answered by AI

What else has been investigated concerning the effects of blinatumomab?

"Originally explored by Huazhong University of Science and Technology's Union Hospital medical college in 2018, blinatumomab has since been the focus of 15 concluded clinical trials. Currently, 5 ongoing studies are recruiting patients located predominantly in Seattle, Washington."

Answered by AI

Is enrollment for this clinical trial currently available to eligible participants?

"According to the clinicaltrials.gov, this medical study is currently searching for suitable applicants. It was initially posted on 9th January 2020 and its last update was 8th July 2022."

Answered by AI

Is this trial pioneering a new approach to therapy?

"Presently, 5 clinical trials for Blinatumomab are underway in 29 different cities and 2 nations. The initial examination of the drug was conducted by Ascentage Pharma Group Inc. in 2018; it involved 60 individuals and culminated with Phase 1 approval. Since then, 15 more examinations have been completed."

Answered by AI

Are there a number of sites actively conducting this research study within the state?

"This research is enrolling patients at 8 sites, including Seattle, Houston and Baltimore. To reduce the amount of travel needed to participate in this trial, you may want to look for a location nearest your home."

Answered by AI
~12 spots leftby Mar 2025