First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Participants with Advanced Solid Tumor
First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Participants with Advanced Solid Tumor
Mechanism of Action
STX-478 is a PI3Kα small molecule inhibitor.
Purpose
- How much of the study can be given with an acceptable level of side effects
- The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)
- Has a new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen within 10 years prior to screening
- Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types) obtained either from tumor or plasma samples, determined by PCR or NGS-based assay as an FDA-approved test in US, CE marked in EU, or obtained as part of normal clinical care in a CLIA certified or similarly certified laboratory. (PI3Kα H1047X, M1043X, or G1049X HR+ Breast, Solid tumors; [PI3Kα E542X or E545X] solid tumors)
- Has an ECOG performance status score of 0 or 1 at screening
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied
- Has symptomatic brain or spinal metastases
- Has a tumor with known mutations/deletions in PTEN and activating mutations in AKT (E17K) confirmed by a CLIA-certified or similarly certified laboratory
- Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2 (based on FPG and HbA1c thresholds defined in the inclusion criteria) requiring antihyperglycemic medication
- Cohorts A0, A1, A2, A3, A4, A5 and B: Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
- Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy
- Has had radiotherapy within 14 days before the initiation of study treatment
Cohorts A0, A1, A2, A3, A4, B: Has had prior treatment with PI3K/AKT/mTOR inhibitor(s) Note: Participants in Cohort A0 may have received prior treatment with an approved PI3Kinhibitor. Upon approval by the sponsor, participants in Cohort A0 who have prematurely discontinued treatment with an approved PI3K-inhibitor due to intolerance may be included. Has a tumor with mutations/deletions in PTEN and activating mutations in AKT or mTOR confirmed by a CLIA-certified laboratory
Location
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