๐ฌIn 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.
๐ 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 โค 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) โฅ8%
* Currently requiring insulin
* Fasting blood glucose (FBG) โฅ140 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.
START Midwest
Grand Rapids, United States
NEXT Oncology - Dallas
Irving, United States
NEXT Virginia
Fairfax, United States
๐ค 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.