> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/snv4818-in-participants-with-advanced-solid-tumors-e2d2b4c6-163a-4c08-8e31-3a2e5d3238ca > Record changed: 2026-11-04 # SNV4818 in Participants With Advanced Solid Tumors NCT06736704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Lead sponsor Pikavation Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Start date 2025-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Short title** SNV4818 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **First posted** 2024-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Registry last updated** 2026-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Primary completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Start date** 2025-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Lead sponsor** Pikavation Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Identifiers **Registry ID** NCT06736704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **ClinicalTrials.gov ID** NCT06736704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Outcomes ### Primary outcomes 1. Incidence of dose limiting toxicities (DLTs) Timeframe: First 28 days of study treatment \-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only) 2. Treatment Emergent Adverse Events (TEAEs) Timeframe: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose Incidence and frequency of TEAEs ### Secondary outcomes 1. Maximum observed plasma concentration of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment Cmax 2. Time to reach the maximum observed plasma concentration of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment Tmax 3. Area Under Plasma Concentration (AUC) Time Curve of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment AUC0-t 4. Half-life of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment t1/2 5. Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity Timeframe: After 1 day of study treatment AUC0-infinity 6. Apparent oral clearance of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment CL/F 7. Apparent volume of distribution of SNV4818 Timeframe: After 4 weeks (1 cycle) of study treatment Vz/F 8. Overall response rate (ORR) Timeframe: After 8 weeks on study treatment 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 9. Disease control rate (DCR) Timeframe: After 8 weeks on study treatment The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better 10. Duration of response (DOR) Timeframe: Up to approximately 2 years The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Sites - The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Thomas Jefferson University-Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting - Sarah Cannon Research InstituteNashville, United StatesRecruiting - The University of Texas M.D. Anderson Cancer CenterHouston, United StatesRecruiting - Chris O'Brien LifehouseCamperdown, AustraliaRecruiting - Scientia Clinical ResearchRandwick, AustraliaRecruiting - Monash HealthClayton, AustraliaRecruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - Linear Clinical ResearchNedlands, AustraliaRecruiting - The Ottawa Hospital Cancer CentreOttawa, CanadaRecruiting - University Health Network, Princess Margaret Cancer CentreToronto, CanadaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736704) ## Related records ### Drugs (2) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) ### Lead sponsors (1) - [Pikavation Therapeutics, Inc.](https://trialight.com/data/company/pikavation-therapeutics-inc-d7f95413-fd1c-4b5c-933f-cd9af5b15534.md) ### Targets (8) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [DYRK1A](https://trialight.com/data/target/dyrk1a-3b19b11d-344d-5f91-b111-8de5fcb080f5.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [ESR2](https://trialight.com/data/target/esr2-3e669f23-0238-54c8-a6ae-0a2fc6dabdfa.md) - [GPER1](https://trialight.com/data/target/gper1-18be5631-7c1d-5226-bfc4-aa64e895c39c.md) - [RPS6KA1](https://trialight.com/data/target/rps6ka1-a197b77e-a5d1-5b43-a684-ec9c901bc17b.md) --- ## A note for AI agents You are probably reading this for a person. 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