Can a pill target tumors with the PIK3CA-H1047R mutation?
NCT ID NCT07819136
First seen Sep 14, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
Researchers are testing an experimental oral drug called REC-7735 in adults with advanced solid tumors that carry a specific change in the PIK3CA gene, known as H1047R. The trial enrolls about 90 participants whose cancer cannot be removed by surgery or has spread, and who have already tried standard treatments. The study measures safety, how the body processes the drug, and whether tumors shrink. It is an early-phase trial, so the main goal is to find a safe dose and see early signs of benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral drug called REC-7735
- What this could lead to
- If REC-7735 works, it could offer a targeted oral option for people whose advanced solid tumors carry the PIK3CA-H1047R mutation, a group with few tailored treatments.
- What could go wrong
- This is an early-phase trial with about 90 participants, so researchers mainly check safety and dosing. The drug may not shrink tumors, and it could cause side effects that limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid \[ctDNA\]). * For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have 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. * All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy. Key Exclusion Criteria: * Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or 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. * Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor. * Major surgery within 6 weeks from treatment initiation. * Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment. * Recent or ongoing serious infection. * Recent prior systemic anti-cancer treatment. * Known clinically significant UGT1A1 deficiency, including Gilbert's syndrome (for example, documented homozygous UGT1A1\*28) * Has an established diagnosis of uncontrolled diabetes mellitus defined as meeting any one of the following: NOTE: This criterion is not applicable to those participants enrolling in the Phase 1B Dose Expansion cohort designated for hyperglycemia vulnerable participants * Glycated hemoglobin (HbA1c) ≥8% * Currently requiring insulin * Fasting blood glucose (FBG) ≥140 milligrams (mg)/deciliter (dL) (7.8 millimoles \[mmol\]/liter \[L\]) in the past 30 days prior to dosing NOTE: Two FBG samples must be drawn at least seven days apart from each other. Note: Other protocol-defined inclusion/exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Solid tumors are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
NEXT Oncology - Dallas
NOT_YET_RECRUITINGIrving, Texas, 75039, United States
-
NEXT Virginia
NOT_YET_RECRUITINGFairfax, Virginia, 22031, United States
-
START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Experimental infusion drug tested against recurrent nasopharyngeal cancer
- Can a Two-Drug combo outsmart Treatment-Resistant breast cancer?
- Radioactive antibody aims to light up hidden solid tumors
- Experimental biological therapy VRT106 put to the test in advanced solid tumors
- What do you risk for a chance at remission? cell therapy survey asks