Advanced Solid CancerPhase 1NCT06666270
Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors
A Phase 1 study testing SYN818 in people with Advanced Solid Cancer and Metastatic Solid Tumor, run by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd at 2 sites in China.
Trial summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancer, Metastatic Solid Tumor, Ovarian Cancer
- What is being tested?
- SYN818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 21 Nov 2024to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed the written Informed Consent Form (ICF);
- Male or female aged ≥18 years;
- Life expectancy ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
- Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted;
- be willing to provide tumor tissue samples (fresh frozen [SF] or previously retained paraffin-embedded [FFPE] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing [NGS])
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- At least one measurable lesion according to RECIST v1.1;
- No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;
- Adequate organ function and bone marrow function.
Who cannot join
- Previous or current use of POLQ inhibitors;
- Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818;
- Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
- Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast;
- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
- Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;
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- Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug;
- History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4/BCRP/P-gp during the study;
- Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center.
Shanghai, Shanghai Municipality, 200032
Hongxia Wnag, MD, PhD, +86-21-64175590, whx365@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Min Yan, MD, PhD, +86-371-65588007, ym200678@126.com
About this study
Official title: A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors
Read the detailed description
This study is a Phase I, open-label, multicentre study of SYN818 administered orally in patients with advanced solid tumors
- Conditions
- Advanced Solid Cancer, Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer, Prostate Cancer, BRCA Mutation
- Being tested
- SYN818
- Medical subject headings
- Neoplasm Metastasis, Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN818Drug
Patients will orally receive SYN818
| Study group | Role | What they receive |
|---|---|---|
| SYN818 tablet | Experimental | SYN818 tablet monotherapy Receives: Drug: SYN818 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.
Measured: From time of information consent to 30 days post last dose, up to 3 years
Maximum tolerated dose (MTD)
MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
Measured: Up to 3 years
Secondary outcomes (5)
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change
Blood drug concentrations at each scheduled time point will be summarized descriptively, and individual and mean concentration-time curves will be plotted by dose group.
Measured: Up to 3 years
Objective Response Rate (ORR)
ORR is defined as proportion of patients who achieved complete response (CR) or partial response (PR) according to RECIST 1.1 recorded from first investigational product treatment until disease progression or death due to any cause. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks. For castration-resistant prostate cancer (CRPC) patients, bone lesion will be assessed according to PCWG3 criteria.
Measured: Up to 3 years
Duration of Response (DoR) and Time to Response (TTR)
DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.
Measured: Up to 3 years
Progression Free Survival (PFS)
PFS is defined as the time from the first study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause.
Measured: Up to 3 years
Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)
The tests for the above serum tumor markers will support the tumor response evaluation.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start21 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666270
- Sponsor's protocol ID
- SYN-818-101
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06666270
- Acronym / sponsor ID
- SYN-818-101
- Conditions
- Advanced Solid Cancer, Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer, Prostate Cancer, BRCA Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hangzhou SynRx Therapeutics Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (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 interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors
Detailed description
This study is a Phase I, open-label, multicentre study of SYN818 administered orally in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYN818 tablet | Experimental | Drug: SYN818SYN818 tablet monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having signed the written Informed Consent Form (ICF);
- Male or female aged ≥18 years;
- Life expectancy ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
- Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted;
Key exclusion criteria (9 listed)
- Previous or current use of POLQ inhibitors;
- Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818;
- Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
- Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast;
- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
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 |
|---|---|---|
| SYN818Patients will orally receive SYN818 | Drug | SYN818 tablet |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Time frame: From time of information consent to 30 days post last dose, up to 3 years
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.
Maximum tolerated dose (MTD)
Time frame: Up to 3 years
MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
5 secondary outcomes
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change
Time frame: Up to 3 years
Objective Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DoR) and Time to Response (TTR)
Time frame: Up to 3 years
Progression Free Survival (PFS)
Time frame: Up to 3 years
Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYN818 in people with Advanced Solid Cancer and Metastatic Solid Tumor, run by Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd at 2 sites 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tongfu Xu, PHD (+86-571-86360796, xutongfu@synrx.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)). The study lists 3 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 20 Jul 2025.