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NCT07819136From ClinicalTrials.govRecruiting

REC-7735 in Participants With Solid Tumors

A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors

  • Solid Tumors

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Recursion Pharmaceuticals Inc.
Enrolment target
90
Started
September 2026
Main results due
January 2031
Study sites
3
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(3)

  • START Midwest

    Grand Rapids, Michigan, United States

    Recruiting

  • NEXT Oncology - Dallas

    Irving, Texas, United States

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, United States

    Recruiting

Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07819136. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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REC-7735 in Participants With Solid Tumors | Trialion