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Advanced Refractory Solid TumorsPhase 1NCT04324372

Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors

A Phase 1 study testing HEC68498 in people with Advanced Refractory Solid Tumors, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498 in patients with advanced refractory solid tumors Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Refractory Solid Tumors
What is being tested?
HEC68498
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
27 Feb 2019to 26 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • （1）Target subjects
  • 18 years of age ≤ age ≤ 70 years of age, regardless of gender;
  • Patients with various types of advanced solid tumors confirmed by cytological or histological examination.
  • Dose escalation test phase: including breast cancer, colorectal cancer, neuroendocrine tumors, etc .; Extended trial phase: limited to patients with HR + / HER2-, triple-negative, breast, colorectal, and neuroendocrine tumors, and patients with HR + / HER2- and colorectal cancer need genetic testing (blood and / or tumor tissue) PIK3CA mutations have been confirmed. Patients with triple negative breast cancer need genetic testing (blood and / or tumor tissue) to confirm PIK3CA / PTEN- mutations.
  • Requires at least standard treatment failure or no standard treatment. Definition of treatment failure: a. Disease progression during or after treatment must have clear imaging or clinical evidence; b. Withdrawal from treatment due to intolerable response.
  • According to the solid tumor evaluation criteria (RECIST 1.1), there is at least one measurable lesion.
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  • Relieve from previous chemotherapy, hormone therapy, targeted therapy, radiotherapy or surgical treatment of toxic reactions (according to CTCAE v5.0 grading ≤ 1 except hair loss)
  • ECOG score is 0 or 1 (see Annex 2 for ECOG score criteria);
  • Expected survival time ≥ 12 weeks;
  • The subject must have proper organ function
  • Blood routine: absolute neutrophil (ANC) ≥ 1.5 × 109 / L; platelet (PLT) ≥ 75 × 109 / L; hemoglobin (Hb) ≥ 90 g / L; Have received hematopoietic cell colony-stimulating growth factors (eg G-CSF, GM-CSF) or have not received blood transfusions. Erythropoietin or erythropoietin therapy can be maintained if it is used immediately before enrollment.
  • Liver function: ALT and AST ≤ 2.5 × ULN (for patients with liver metastases, ALT and AST can be relaxed to ≤ 5.0 × ULN); serum bilirubin ≤ 1.5 × ULN;
  • Renal function: serum creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 60 mL / min calculated according to the Cockcroft-Gault formula:
  • Urine routine urinary protein ≤ 1+; if urinary routine urinary protein ≥ 2+, a 24-hour urine protein quantification is less than 1 g.
  • Electrolyte: LLN ≤ blood potassium ≤ ULN;
  • Coagulation function: international standardized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN;

Who cannot join

  • previous treatment history
  • Have previously been treated with PI3K inhibitors, mTOR inhibitors (such as everolimus) or AKT inhibitors.
  • Patients who have received targeted therapy within 4 weeks before the first dose or ≤ 5 × drug half-life (if the half-life of the drug is specified, it is calculated as 5 times the half-life, otherwise 4 weeks);
  • Patients who have received chemotherapy, hormonal antitumor therapy, immunotherapy or major surgery within 4 weeks before the first dose.
  • Note: If the previous treatment was nitrosourea or mitomycin, the treatment must be discontinued at least 6 weeks before the first study drug is administered.
  • Patients who have received radiation therapy within 4 weeks before the first dose.
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  • Have received clinical trial drug treatment within 4 weeks before the first medication, or are receiving other clinical trial drug treatment;
  • History of disease and surgery
  • CNS metastases requiring current treatment or uncontrolled CNS metastases; or CNS metastases confirmed but not stable for more than 4 weeks after treatment;
  • Patients with spinal cord compression, cancerous meningitis, or meningitis;
  • Currently diagnosed with type I or type II diabetes or fasting blood glucose levels> 6.7 mmol / L, or HbA1c> 7%;
  • Patients with hypertension controlled by two or more drugs, or uncontrolled hypertension (systolic blood pressure> 140 mmHg or diastolic blood pressure> 90 mmHg);
  • Left ventricular ejection fraction (LVEF) <50%; QTcF> 450 ms for men, QTcF> 470 ms for women (QTcF is calculated using Fridericia's correction formula QTcF = QT / RR 0.33); any room with obvious clinical significance History of arrhythmia (such as ventricular tachycardia, ventricular fibrillation, torsional ventricular tachycardia or frequent ventricular premature beats, congenital prolonged QT interval syndrome).
  • Multiple factors affecting oral medication (eg, inability to swallow, chronic diarrhea, and intestinal obstruction, etc.);
  • Patients with a clear tendency to gastrointestinal bleeding, including the following: local active ulcer lesions and positive fecal occult blood; those with a history of melena and vomiting within 2 months before the first medication; researchers believe that digestion may occur Major bleeding

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Fifth Medical Center of PLA Ceneral Hospital

    Beijing, China/BEIJING, 100071

Other trials in China

About this study

Official title: An Open Label Multicentric Phase 1 Study of HEC68498 in Patients With Advanced Refractory Solid Tumors.

Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498 in patients with advanced refractory solid tumors

Read the detailed description

An open label multicentric Phase 1 study of HEC68498 in patients with advanced refractory solid tumors.The study will follow a 3+3 design until significant toxicity as described in the protocol and considering pharmacokinetics of the study drug determined from cohorts.

Being tested
HEC68498

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEC68498Drug

    HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.

Study groups in NCT04324372
Study groupRoleWhat they receive
HEC68498ExperimentalHEC68498 will be administered daily
Receives: Drug: HEC68498

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Patients will receive study drug on a daily basis for 28 days according to the dose and schedule specified for a particular cohort of therapy. Toxicities observed in Cycle 0\&1 will be considered for dose limiting toxicity (DLT) and Maximum tolerated dose (MTD)determination

    Measured: 28 days

Secondary outcomes (8)

  1. Number of subject with adverse events

    The toxic effects of the drug would be assessed from adverse events, vital signs and by clinically significant changes in the laboratory evaluations.

    Measured: up to 4 weeks after last dose

  2. Objective response

    Evaluation of Response: Clinical responses will be presented patient wise for different dose levels.

    Measured: up to approximately 24 months

  3. AUC0-∞

    area under the concentration versus time curve (AUC) from time zero to infinity

    Measured: up to approximately 4 weeks

  4. AUC0-t

    AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration

    Measured: up to approximately 4 weeks

  5. Cmax

    maximum observed plasma concentration

    Measured: up to approximately 4 weeks

  6. tmax

    time of the maximum observed plasma concentration

    Measured: up to approximately 4 weeks

  7. t½

    apparent terminal elimination half-life

    Measured: up to approximately 4 weeks

  8. Vz/F

    apparent volume of distribution

    Measured: up to approximately 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start27 Feb 2019
  3. Primary completion26 Feb 2021
  4. Study completion26 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04324372
Sponsor's protocol ID
HEC68498-P-01
Status last verified
Aug 2022
First submitted
18 Mar 2020
Last updated
12 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEC68498 in people with Advanced Refractory Solid Tumors, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04324372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.

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