OpenLong-term Hope (5+ yrs) / Medium-term (3–5 yrs)Treatment Study
REC-7735 in Participants With Solid Tumors
For Condition: Solid Tumors
ID: NCT07819136
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Pills / Oral Tablets
Expected Availability Horizon
Long-term Hope (5+ yrs away) / Medium-term (3–5 yrs away)
StageEarly Clinical Stage: Focuses strictly on testing basic safety, toxicity, and dosage in a small group (10–50 people). Represents early-stage scientific hope.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
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 Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
90 patients (Estimated)
Study Start Date
2026-09
Est. Primary Completion
2031-01
Tested Drugs & Treatment Groups
DRUGREC-7735
Oral
Treatment Arms Description
EXPERIMENTALPhase 1A Dose Finding: REC-7735
Participants will receive REC-7735 twice daily (BID).
EXPERIMENTALPhase 1B Dose Expansion/Optimization: REC-7735
Participants will receive REC-7735 BID.
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can Join
- 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.
Who Cannot Join
- 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.
What is this Study Measuring?
Primary Outcome Measures
- 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
View Secondary Outcome Measures (10)
- Maximum (Peak) Drug Concentration (Cmax) of REC-7735 — Time Frame: Up to 2 years
- Time to Reach Cmax following drug administration (Tmax) of REC-7735 — Time Frame: Up to 2 years
- Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735 — Time Frame: Up to 2 years
- Phase 1A: ORR According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1 — Time Frame: Up to 2 years
- Phase 1B: Overall Survival — Time Frame: Up to 2 years
Where to Participate
This trial is recruiting at 3 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 3 Facilities & Contact Sites
START Midwest
Grand Rapids, Michigan, United States
Status: Open
NEXT Oncology - Dallas
Irving, Texas, United States
Status: Open
NEXT Virginia
Fairfax, Virginia, United States
Status: Open
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
sequential
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Recursion Pharmaceuticals Inc.
Primary Research Contact
Clinical Trial Application Copilot
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
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Subject: Inquiry about clinical trial enrollment: NCT07819136 - REC-7735 in Participants With Solid Tumors
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "REC-7735 in Participants With Solid Tumors" (NCT ID: NCT07819136).
I am [Age] years old and have been diagnosed with Solid Tumors. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific Title
A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors