REC-7735 in Participants With Solid Tumors

NCT07819136 | Recruiting Phase 1 FDA Drug

• 1 other identifier: REC-7735-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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

Keywords

PIK3CA-H1047R; Cancer

Outcome Measures

Primary Outcomes (3)

• Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)

  28 days

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to 2 years

• Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 2 years

Secondary Outcomes (10)

• Maximum (Peak) Drug Concentration (Cmax) of REC-7735

  Up to 2 years

• Time to Reach Cmax following drug administration (Tmax) of REC-7735

  Up to 2 years

• Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735

  Up to 2 years

• Phase 1A: ORR According to Standard RECIST 1.1

  Up to 2 years

• Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1

  Up to 2 years

Study Arms (2)

Phase 1A Dose Finding: REC-7735

EXPERIMENTAL

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

Drug: REC-7735

Phase 1B Dose Expansion/Optimization: REC-7735

EXPERIMENTAL

Participants will receive REC-7735 BID.

Drug: REC-7735

Interventions

REC-7735 DRUG

Oral

Phase 1A Dose Finding: REC-7735; Phase 1B Dose Expansion/Optimization: REC-7735

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recursion Pharmaceuticals Inc.: lead

Study Sites (3)

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NEXT Oncology - Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Recursion Pharmaceuticals

CONTACT

385-374-1724; clinicaltrials@recursionpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)