REC-7735 for PIK3CA-H1047R-mutant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REC-7735 is being studied in adults with solid tumors that have the PIK3CA-H1047R mutation. The trial combines early-phase safety and pharmacology assessments with preliminary signals of anti-tumor activity. Participants may receive REC-7735 as monotherapy in Phase 1B after prior treatment failure or intolerance to standard therapies. Key eligibility includes confirmed mutation status via tumor tissue or ctDNA and adequate organ function, with certain prior-treatment exclusions.

Why it matters

Who can join: the full rules

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.

Where it's running

• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• NEXT Oncology - Dallas
  Irving, Texas, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Recursion Pharmaceuticals
• Email: clinicaltrials@recursionpharma.com
• Phone: 385-374-1724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

• HP007 monotherapy for relapsed or advanced solid tumors

  This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

  Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

• ONO-7429 in advanced or recurrent solid tumors

  This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.

  Recruiting at 10 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 9 other locations · NCT07787208

• BL-M08D in patients with digestive tract and other solid tumors

  A early-stage study to see if BL-M08D1 can be safely given and help people with advanced digestive tract cancers and other solid tumors.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07780318

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.