AzTrials
AzTrials

Advanced or Metastatic Solid TumorsPhase 1NCT05407909

To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1 study testing SYHX2001 in people with Advanced or Metastatic Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the experimental drug(SYHX2001) in previously treated patients with advanced or metastatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
SYHX2001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteChina
Study dates
27 Jul 2022to 6 Jan 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients with an age of 18~75years (inclusive).
  • Confirmed histologic or cytologic diagnosis of an advanced and/or metastatic solid tumor.
  • At least one measurable lesion as defined by RECIST version 1.1.
  • Eastern Cooperative Oncology Group Performance Status 0 or 1.
  • Life expectancy ≥3 months.
  • Major organ function within 14 days prior to treatment meets the following criteria (no blood transfusion, Erythropoietin(EPO), Granulocyte Colony Stimulating Factor(G-CSF) or other medical support): Absolute Neutrophil Count(ANC)≥1.5×10^9/L，Platelet(PLT)≥90×10^9/L，Hemoglobin(Hb)≥100g/L or≥6.2 mmol/L；Creatinine(Cr)≤1.5×upper limit of normal(ULN) and creatinine clearance rate≥50mL/min；Total Bilirubin(TBIL)≤1.5×ULN; Prothrombin time(PT)≤1.5×ULN , Activated Partial Thromboplastin Time(APTT)≤1.5×ULN , Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT)≤2.5 × ULN.
  • Signed informed consent form.

Who cannot join

  • Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks prior to the first dose of the study drug, or administration of other investigational agents within 4 weeks or 5 half-lives prior to the first dose of the study drug, whichever is longer.
  • Major surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
  • Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0。
  • Have a history of severe cardiovascular and cerebrovascular disease.
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled and not suitable for the study according to the judgment of the investigator.
  • Known history of hypersensitivity to test drug components.
Show all 17Show fewer
  • Patients with recent active bleeding or a history of bleeding.
  • Those with coagulation disorders or taking thrombolytic, anticoagulant or antiplatelet agglutination drugs.
  • Gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within 6 months prior to first dose; or currently under investigator's judgement there are high risk factors for hollow organ perforation/fistula formation).
  • Inability to swallow the drug orally, or a condition that seriously affects gastrointestinal absorption in the judgment of the investigator.
  • Irritable bowel syndrome with signs/symptoms requiring medication.
  • Persistent active diarrhea requiring medical treatment.
  • Concomitant use of strong CYP3A4 inhibitors or inducers, strong CYP2D6 inhibitors and strong P-gp inhibitors within 14 days prior to the first dose of the study drug.
  • History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
  • Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or other active viral infection.
  • Male and female patients of childbearing potential do not agree to use suitable method of contraception during the treatment and 6 months after the last dose of study medication; female patients do not have negative results of serum/urine pregnancy test within 7 days prior to enrollment and would be breastfeeding.
  • Not suitable for this study as determined by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

Xiaodong Wang contact

+86 021-60673947

wang_xiaodong@mail.ecspc.com

China1 site, 1 recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Yanqiao Zhang, Professor, 13845120210, yanqiaozhang@126.com

    Recruiting

Other trials in China

About this study

This is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the experimental drug(SYHX2001) in previously treated patients with advanced or metastatic cancer.

Read the detailed description

This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of SYHX2001(name of the experimental drug) in patients with advanced or metastatic cancers who have exhausted standard treatment. The study will consist of 2 parts, a dose escalation part and a cohort expansion part. Once the recommended phase 2 dose (RP2D) has been determined in the dose escalation part, a cohort expansion part involving up to three separate cohorts will be conducted. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of SYHX2001.

Being tested
SYHX2001

What participants receive

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

  • SYHX2001Drug

    SYHX2001 tablets, oral

Study groups in NCT05407909
Study groupRoleWhat they receive
SYHX2001ExperimentalSYHX2001 will be administered orally.
Receives: Drug: SYHX2001

What is being measured

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

  1. Dose limiting toxicities (DLT) in stage Ⅰ

    Measured: Baseline through Day 28

  2. Maximum tolerated dose (MTD) in stage Ⅰ

    Measured: Baseline through Day 28

  3. Recommended phase 2 dose (RP2D)

    Measured: Baseline through approximately 2 years

  4. Incidence and severity of adverse events in stage Ⅰ

    Measured: Baseline through approximately 2 years

  5. Overall response rate (ORR) in stage Ⅱ

    Measured: Up to approximately 2 years

Secondary outcomes (9)

  1. Maximum observed plasma concentration (Cmax) of SYHX2001

    Measured: Baseline and up to approximately 2 years

  2. Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of SYHX2001

    Measured: up to approximately 2 years

  3. AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001

    Measured: up to approximately 2 years

  4. Terminal phase half-life (t1/2) of SYHX2001

    Measured: up to approximately 2 years

  5. Oral clearance (CL/F) of SYHX2001

    Measured: up to approximately 2 years

  6. PFS Progression-free survival (PFS)

    PFS is defined as the time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.

    Measured: up to approximately 2 years

  7. Duration of Response (DOR)

    DOR is defined as the time from first evidence of response (complete response or partial response per RECIST 1.1) to earlier date of disease progression or death due to any cause.

    Measured: up to approximately 2 years

  8. Number of patients with any adverse events(AEs) and serious adverse events(SAEs) in stage Ⅱ

    Measured: up to approximately 2 years

  9. Change from Baseline in symmetrical arginine dimethylation (SDMA) as a pharmacodynamics(PD) measure

    Measured: Baseline and up to approximately 2 years

Timeline

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

  1. First posted7 Jun 2022
  2. Study start27 Jul 2022
  3. Primary completion6 Jan 2026 (estimated)
  4. Study completion6 Jan 2026 (estimated)

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
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407909
Sponsor's protocol ID
SYHX2001C101
Status last verified
Aug 2022
First submitted
30 May 2022
Last updated
9 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYHX2001 in people with Advanced or Metastatic Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 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?

Results are not available in the source record.

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

Contact Xiaodong Wang (+86 021-60673947, wang_xiaodong@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLT) in stage Ⅰ (time frame: Baseline through Day 28). The study lists 5 primary outcomes in all. 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 NCT05407909.

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 9 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in