REC-7735 in Participants With Solid Tumors
Purpose
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.
Condition
- Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
More Details
- Status
- Recruiting
- Sponsor
- Recursion Pharmaceuticals Inc.