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REC-7735 in Participants With Solid Tumors

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllRecursion Pharmaceuticals Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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) โ‰ฅ8% * Currently requiring insulin * Fasting blood glucose (FBG) โ‰ฅ140 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.
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What it tests

  • REC-7735
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Where

3 sites
START Midwest
Grand Rapids, United States
NEXT Oncology - Dallas
Irving, United States
NEXT Virginia
Fairfax, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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