Metastatic CancerPhase 1NCT05544240
Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing SV-101 in people with Metastatic Cancer and Metastatic Breast Cancer, run by Williams Cancer Foundation at 1 site in Mexico.
Trial summary
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Metastatic Breast Cancer, Metastatic Lung Cancer
- What is being tested?
- SV-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2023to 31 Dec 2025
- 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
- Male or female, aged >18 years old at the time of signed informed consent
- Provide written informed consent and must be willing to adhere with treatment and follow-up.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available.
- Meet all eligibility criteria
- Has undergone a cardiac work-up and received cardiac clearance two months before first treatment
- Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.
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- Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.
- Measurable disease by RECIST.
- Able to undergo general anesthesia or conscious sedation.
- Eastern Cooperative Oncology Group (ECOG) performance status of < 3.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the study.Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable doses for at least 42 days prior to the cryolysis
- In the opinion of the Investigator, there is no other meaningful life-prolonging therapy option available.
- Adequate bone marrow, renal, and hepatic function, defined as follows:
- Bone marrow function without transfusion 30 days before first dosing: i. Absolute neutrophil count ≥ 1.5 x 109/L; Lymphocyte count of ≥ 1.0 x 109/L; Platelet count ≥ 100 x 109/L; ii. Hemoglobin ≥ 9.0 g/dL b. Renal function: i. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation ≥30 mL/ c. Hepatic function: i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome iv. Patients with liver metastases ≤5x ULN
- All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline (except alopecia or ototoxicity
- All subjects with female partners of childbearing potential must use effective contraception throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention
- Has at least one lesion that is demonstrable on PET/CT, CT, Ultrasound, or MRI and is accessible for injection
Who cannot join
- Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma
- Has undergone major surgery within 28 days prior to enrollment and has not recovered adequately from the toxicities and/or complications
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has received a live vaccine within 30 days prior to enrollment
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first treatment
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- Has tumor volume or disease burden too great to provide for safe and/or effective treatment as determined by the Principal Investigator after consultation with Syncromune's Chief Medical Officer
- Subjects who have metastases limited to subcutaneous regions (only skin)
- Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.
- Malignant pleural effusions or ascites that require immediate intervention
- Prior history of autoimmune disease except hypothyroidism
- Any primary or acquired immunodeficiency
- Active COVID infection or tests positive for COVID day before or day of planned treatment
- Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion)
- Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load
- Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes, cardiac arrhytmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate.Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Diomed
Mexico City, 11810
Jason Williams, MD, 1-954-530-4606, dr@williamscancerinstitute.com
About this study
Official title: Phase 1 Trial of SYNC-T - Immunotherapy Regimen Given After Controlled Cellular Lysis for Patients With Advanced/Metastatic Solid Tumors
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
- Being tested
- SV-101
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV-101Drug
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment Arm Receives: Drug: SV-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity
To assess the preliminary antitumor activity of SV-101 as measured by RECIST 1.1 and iRECIST
Measured: 4-6 weeks after each treatment
Secondary outcomes (1)
To evaluate rate of adverse events (AEs), including serious adverse events (SAEs) and AEs leading to treatment discontinuation
Safety assessment will include protocol-specified periodic physical examination findings, vital signs, ECOG performance status, protocol-specified laboratory variables (e.g. hematology, coagulation tests, serum chemistry, urine tests), AEs using CTCAE v5.1, and SAEs.
Measured: Beginning at baseline and including pre-intervention/procedure and through study completion over 1 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Feb 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Williams Cancer Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Syncromune, Inc.
- Responsible party
- Principal investigator, Jason Williams, MD, Williams Cancer Foundation
- Investigators
- Jason Williams, MD, Principal investigator, Williams Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544240
- Sponsor's protocol ID
- Phase 1 SV-101
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of SYNC-T - Immunotherapy Regimen Given After Controlled Cellular Lysis for Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05544240
- Acronym / sponsor ID
- Phase 1 SV-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Williams Cancer FoundationUniversity, hospital or other
- Collaborators
- Syncromune, Inc.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Sep 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.
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: SV-101Treatment Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female, aged >18 years old at the time of signed informed consent
- Provide written informed consent and must be willing to adhere with treatment and follow-up.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available.
- Meet all eligibility criteria
- Has undergone a cardiac work-up and received cardiac clearance two months before first treatment
Key exclusion criteria (16 listed)
- Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma
- Has undergone major surgery within 28 days prior to enrollment and has not recovered adequately from the toxicities and/or complications
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has received a live vaccine within 30 days prior to enrollment
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 |
|---|---|---|
| SV-101SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects. | Drug | Treatment Arm |
Primary outcome
Antitumor activity
Time frame: 4-6 weeks after each treatment
To assess the preliminary antitumor activity of SV-101 as measured by RECIST 1.1 and iRECIST
1 secondary outcome
To evaluate rate of adverse events (AEs), including serious adverse events (SAEs) and AEs leading to treatment discontinuation
Time frame: Beginning at baseline and including pre-intervention/procedure and through study completion over 1 year period
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 6 Apr 2025.
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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.
Jason Williams, MD principal investigator
Williams Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SV-101 in people with Metastatic Cancer and Metastatic Breast Cancer, run by Williams Cancer Foundation at 1 site in Mexico.
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 17 inclusion and 16 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 6 Apr 2025. 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 Mexico. 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 Jason Williams, MD ((954) 530-4606, dr@williamscancerinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antitumor activity (time frame: 4-6 weeks after each treatment). 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 6 Apr 2025.