OncoMatch/Clinical Trials/NCT07819136
REC-7735 in Participants With Solid Tumors
Official title: A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors
Is NCT07819136 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies REC-7735 for solid tumors.
Treatment: REC-7735 — The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: PIK3CA h1047r
solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid [ctDNA])
Excluded: PTEN loss-of-function mutation
Known loss-of-function mutations in phosphatase and tensin homolog (PTEN)
Excluded: PTEN loss
PTEN loss
Excluded: AKT1 activating mutation
activating mutations in AKT
Prior therapy
Must have received: systemic anti-cancer therapy — for a given tumor type
experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy
Cannot have received: PI3K inhibitor
Exception: unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka)...inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Cannot have received: AKT inhibitor
Exception: unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Participants have experienced disease progression with a...protein kinase B (AKT)...inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Cannot have received: mTOR inhibitor
Exception: unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Participants have experienced disease progression with a...mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START Midwest · Grand Rapids, Michigan
- NEXT Oncology - Dallas · Irving, Texas
- NEXT Virginia · Fairfax, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07819136 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PI3K inhibitor, AKT inhibitor, mTOR inhibitor disqualifies patients from enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA h1047r is a required biomarker for enrollment.
Are patients with PTEN alterations eligible?
No. PTEN loss-of-function mutation is an exclusion criterion.
Are patients with PTEN alterations eligible?
No. PTEN loss is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify