Advanced Solid TumorsPhase 1/2NCT06736704
SNV4818 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing SNV4818, Fulvestrant and Palbociclib in people with Advanced Solid Tumors, run by Pikavation Therapeutics, Inc. at 12 sites in 3 countries.
Trial summary
This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SNV4818, Fulvestrant and Palbociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 20 Feb 2025to Jun 2027
- Phase
- Phase 1/2
- 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
- Advanced or metastatic solid tumor with an activating PIK3CA mutation.
- Refractory to or intolerant of available therapies
- Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Diagnosis of a primary CNS malignancy
- Active brain metastases or carcinomatous meningitis
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Inadequate organ function
- Clinically significant ECG abnormalities, including QTcF ≥ 470 ms
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Thomas Jefferson University-Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Australia5 sites, 5 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
- Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
- Conditions
- Advanced Solid Tumors
- Being tested
- SNV4818, Fulvestrant, Palbociclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNV4818Drug
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
FulvestrantDrug
Also called Faslodex
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
PalbociclibDrug
Also called Ibrance
Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily
| Study group | Role | What they receive |
|---|---|---|
| SNV4818 Monotherapy | Experimental | Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. Receives: Drug: SNV4818 |
| SNV4818+Fulvestrant Combination | Experimental | Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. Receives: Drug: SNV4818; Drug: Fulvestrant |
| SNV4818+Palbociclib+Fulvestrant Combination | Experimental | Participants will receive oral, daily doses of SNV4818 in combination with a standard doses of Palbociclib and Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. Receives: Drug: SNV4818; Drug: Fulvestrant; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Measured: First 28 days of study treatment
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of TEAEs
Measured: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
Secondary outcomes (10)
Maximum observed plasma concentration of SNV4818
Cmax
Measured: After 4 weeks (1 cycle) of study treatment
Time to reach the maximum observed plasma concentration of SNV4818
Tmax
Measured: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818
AUC0-t
Measured: After 4 weeks (1 cycle) of study treatment
Half-life of SNV4818
t1/2
Measured: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
AUC0-infinity
Measured: After 1 day of study treatment
Apparent oral clearance of SNV4818
CL/F
Measured: After 4 weeks (1 cycle) of study treatment
Apparent volume of distribution of SNV4818
Vz/F
Measured: After 4 weeks (1 cycle) of study treatment
Overall response rate (ORR)
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
Measured: After 8 weeks on study treatment
Disease control rate (DCR)
The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better
Measured: After 8 weeks on study treatment
Duration of response (DOR)
The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.
Measured: 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.
- First posted17 Dec 2024
- Study start20 Feb 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pikavation Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736704
- Sponsor's protocol ID
- SNV4818-101
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06736704
- Acronym / sponsor ID
- SNV4818-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Pikavation Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Dec 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 study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNV4818 Monotherapy | Experimental | Drug: SNV4818Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
| SNV4818+Fulvestrant Combination | Experimental | Drug: SNV4818, Drug: FulvestrantParticipants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
| SNV4818+Palbociclib+Fulvestrant Combination | Experimental | Drug: SNV4818, Drug: Fulvestrant, Drug: PalbociclibParticipants will receive oral, daily doses of SNV4818 in combination with a standard doses of Palbociclib and Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced or metastatic solid tumor with an activating PIK3CA mutation.
- Refractory to or intolerant of available therapies
- Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (5 listed)
- Diagnosis of a primary CNS malignancy
- Active brain metastases or carcinomatous meningitis
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Inadequate organ function
- Clinically significant ECG abnormalities, including QTcF ≥ 470 ms
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 |
|---|---|---|
| SNV4818SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm. | Drug | SNV4818 Monotherapy, SNV4818+Fulvestrant Combination, SNV4818+Palbociclib+Fulvestrant Combination |
| FulvestrantAlso: FaslodexFulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections) | Drug | SNV4818+Fulvestrant Combination, SNV4818+Palbociclib+Fulvestrant Combination |
| PalbociclibAlso: IbrancePalbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily | Drug | SNV4818+Palbociclib+Fulvestrant Combination |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: First 28 days of study treatment
-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Treatment Emergent Adverse Events (TEAEs)
Time frame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
Incidence and frequency of TEAEs
10 secondary outcomes
Maximum observed plasma concentration of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Time to reach the maximum observed plasma concentration of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Half-life of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
Time frame: After 1 day of study treatment
Apparent oral clearance of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Apparent volume of distribution of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Overall response rate (ORR)
Time frame: After 8 weeks on study treatment
Disease control rate (DCR)
Time frame: After 8 weeks on study treatment
Duration of response (DOR)
Time frame: Up to approximately 2 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 13 Mar 2026.
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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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SNV4818, Fulvestrant and Palbociclib in people with Advanced Solid Tumors, run by Pikavation Therapeutics, Inc. at 12 sites in 3 countries.
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 4 inclusion and 5 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Robert Casper (443-764-9527, rcasper@synnovationtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) (time frame: First 28 days of study treatment). 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 13 Mar 2026.