Informations générales (source: ClinicalTrials.gov)
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 Tumors
Interventional
Phase 1/Phase 2
Scorpion Therapeutics, Inc. (Voir sur ClinicalTrials)
avril 2023
février 2029
31 mai 2025
Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety,
tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478
(LY4064809) in participants with advanced solid tumors with P13Ka mutations.
Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors.
Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in
participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate
STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant
or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib)
in participants with HR+ breast cancer.
Each study part will include a 28-day screening period, followed by treatment with
STX-478 monotherapy or combination therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 25/06/2024 12:41:28 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Bergonie City: Bordeaux - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Has an advanced or refractory solid tumor malignancy that is metastatic or locally
advanced and unresectable (as specified by Cohort)
2. Has a new or recent tumor biopsy (collected at screening, if feasible) or will
provide an adequate tissue sample prior to screening
3. Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for
cohort-specific mutation types)
4. Is ≥18 years of age at the time of signing the ICF
5. Has an ECOG performance status score of 0 or 1 at screening
6. Has adequate organ function as defined per protocol
Key
1. Has an advanced or refractory solid tumor malignancy that is metastatic or locally
advanced and unresectable (as specified by Cohort)
2. Has a new or recent tumor biopsy (collected at screening, if feasible) or will
provide an adequate tissue sample prior to screening
3. Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for
cohort-specific mutation types)
4. Is ≥18 years of age at the time of signing the ICF
5. Has an ECOG performance status score of 0 or 1 at screening
6. Has adequate organ function as defined per protocol
Key
1. Has history (within ≤2 years before screening) of a solid tumor or hematological
malignancy that is histologically distinct from the cancers being studied
2. Has symptomatic brain or spinal metastases
3. Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8%
and/or FBG ≥140 mg/dL [7.7 mmol/L] and/or requiring or required insulin).
4. Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain
circumstances
5. 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. Endocrine therapy does not require a washout period if the patient is
enrolling in a cohort with the same combination endocrine therapy.
6. 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.
7. Has had radiotherapy within 14 days before the initiation of study treatment