Advanced Solid TumorsPhase 1NCT05609019
A Study Evaluating SYHX2005 in the Treatment of Patients With Advanced Solid Tumors
A Phase 1 study testing SYHX2005 in people with Advanced Solid Tumors, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SYHX2005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2025
- 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
- Age 18~70 years old (inclusive).
- Patients with advanced solid tumors diagnosed histologically or cytologically.
- Could provide tumor tissue sections or agree to take biopsy for central laboratory biomarker detection.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of at least 3 months.
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- Adequate organ function.
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug. Female with child bearing potential must have had a negative serum pregnancy test and must be non-breastfeeding.
- Provide written informed consent voluntarily.
Who cannot join
- Prior treatment with selective FGF19-FGFR4 inhibitor and / or treatment with Pan FGFR inhibitor.
- Received any anti-tumor treatment within 4 weeks before the first use of the study drug.
- Treatment with surgery, COVID-19 vaccine, or investigational drug within 4 weeks prior to the first study treatment administration.
- CYP3A4 strong inducer used within 14 days prior to the first administration or required during the study, or CYP3A4 strong inhibitor have used within 1 week before the first study treatment administration; or CYP3A4 strong inhibitor and P-gp, BCRP transporter strong inhibitor have to be used during the study.
- Patients with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy.
- Other malignant tumors requiring any active treatment at the same time.
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- CNS metastases that are untreated or symptomatic or uncontrolled, so it is not suitable to be included in the group according to the judgment of the investigator.
- Pleural/peritoneal fluid or pericardial effusion with clinical signs or requiring symptomatic management.
- Active infection and need systemic anti infection treatment within 7 days before the first use of the study drug.
- History of autoimmune diseases and immunodeficiency, including HIV positive test, or have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation.
- Active hepatitis B, hepatitis C virus infection.
- History of uncontrollable or serious cardiovascular and cerebrovascular diseases.
- Unable to swallow drugs orally, or there are conditions that seriously affect gastrointestinal absorption as judged by the investigator.
- Symptomatic irritable bowel syndrome and requires treatment.
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- The investigator believes that the patients are not suitable for this clinical study due to other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SYHX2005 in Patients With Advanced Solid Tumors
This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
- Conditions
- Advanced Solid Tumors
- Being tested
- SYHX2005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX2005Drug
Tablets. Take orally.
| Study group | Role | What they receive |
|---|---|---|
| SYHX2005 | Experimental | Stage1 dose-escalation: Patients with advanced solid tumors will receive escalating doses of SYHX2005 as monotherapy.
Stage2 dose-expansion: Patients with advanced solid tumors will receive SYHX2005 monotherapy at recommended dose (1 or 2 ) in Stage 1 (dose escalation) to evaluate the preliminary antitumor activity of SYHX2005. Receives: Drug: SYHX2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)
Maximum tolerated dose
Measured: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR) in stage 2
Overall Response Rate
Measured: up to approximately 2 years
Secondary outcomes (7)
Occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Rate of adverse events (AE) and serious adverse events (SAE)
Measured: 12 months
Overall Response Rate (ORR) in stage 1
Overall Response Rate
Measured: 12 months
Duration of Response (DOR)
Duration of Response
Measured: 12 months
Disease Control Rate (DCR)
Disease Control Rate
Measured: 12 months
Progression-Free Survival (PFS)
Progression-free survival
Measured: 12 months
Overall Survival (OS)
Overall Survival
Measured: 12 months
Pharmacokinetic profile,e.g.AUC of SYHX2005
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609019
- Sponsor's protocol ID
- SYHX2005-CSP-001
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SYHX2005 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05609019
- Acronym / sponsor ID
- SYHX2005-CSP-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYHX2005 | Experimental | Drug: SYHX2005Stage1 dose-escalation: Patients with advanced solid tumors will receive escalating doses of SYHX2005 as monotherapy. Stage2 dose-expansion: Patients with advanced solid tumors will receive SYHX2005 monotherapy at recommended dose (1 or 2 ) in Stage 1 (dose escalation) to evaluate the preliminary antitumor activity of SYHX2005. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18~70 years old (inclusive).
- Patients with advanced solid tumors diagnosed histologically or cytologically.
- Could provide tumor tissue sections or agree to take biopsy for central laboratory biomarker detection.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (17 listed)
- Prior treatment with selective FGF19-FGFR4 inhibitor and / or treatment with Pan FGFR inhibitor.
- Received any anti-tumor treatment within 4 weeks before the first use of the study drug.
- Treatment with surgery, COVID-19 vaccine, or investigational drug within 4 weeks prior to the first study treatment administration.
- CYP3A4 strong inducer used within 14 days prior to the first administration or required during the study, or CYP3A4 strong inhibitor have used within 1 week before the first study treatment administration; or CYP3A4 strong inhibitor and P-gp, BCRP transporter strong inhibitor have to be used during the study.
- Patients with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYHX2005Tablets. Take orally. | Drug | SYHX2005 |
Primary outcome
Maximum Tolerated Dose(MTD)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose
Overall Response Rate (ORR) in stage 2
Time frame: up to approximately 2 years
Overall Response Rate
7 secondary outcomes
Occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
Overall Response Rate (ORR) in stage 1
Time frame: 12 months
Duration of Response (DOR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Pharmacokinetic profile,e.g.AUC of SYHX2005
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYHX2005 in people with Advanced Solid Tumors, run by CSPC Ouyi Pharmaceutical Co., Ltd..
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 9 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jia Fan, MD (+86-021-64041990, fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.