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RecruitingLast updated: 16 December 2025

A study recruiting people with advanced solid cancers to test whether a drug called SNV4818 is safe, well-tolerated, and effective at treating cancerA Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical 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 cancers. They are investigating different doses in order to find the safest and most effective one.

The study has two experimental treatment arms.

In the SNV4818 monotherapy arm, participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. 

In the SNV4818 + Fulvestrant combination arm, participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant (given as an injection into the muscle) as part of either dose escalation or dose expansion cohorts. 

In both arms, 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. 

Conditions

This trial is treating patients with advanced or metastatic solid cancer with an activating PIK3CA mutation

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Pikavation Therapeutics, Inc.

Scientific Title

A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors

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