Recruiting
Phase 1
Phase 2

REC-7735

Sponsor:

Recursion Pharmaceuticals Inc.

Code:

NCT07819136

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REC-7735

Study Details

Brief summary:

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.

Conditions

Solid Tumors

Study ID

NCT07819136

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1A Dose Finding: REC-7735

Participants will receive REC-7735 twice daily (BID).

experimental: Phase 1B Dose Expansion/Optimization: REC-7735

Participants will receive REC-7735 BID.

Interventions

REC-7735

Oral

Primary outcome measure

  • Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years ]
  • Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Recursion Pharmaceuticals

385-374-1724clinicaltrials@recursionpharma.com

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Hope Team Distribution List

hopeteam@startresearch.com

NEXT Oncology - Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Clinical Trial Navigator

972-893-8800fakinwale@nextoncology.com

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Referral Coordinator

703-783-4518mdelarosa@nextoncology.com

More Information

Sponsor

Recursion Pharmaceuticals Inc.

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • PIK3CA-H1047R
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Recursion Pharmaceuticals Inc. on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.