Breast Cancer Clinical Trial
Official title:
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
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 in participants with advanced solid tumors with certain mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors and breast cancer; Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | February 28, 2029 |
Est. primary completion date | February 28, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key 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 archival tumor specimen within 10 years prior to screening 3. Has a tumor that harbors a documented PI3Ka 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. 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 Key Exclusion Criteria: 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 a tumor with known mutations/deletions in PTEN and activating mutations in AKT (E17K) confirmed by a CLIA-certified or similarly certified laboratory 4. 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 5. Cohorts A0, A1, A2, A3, A4, A5 and B: Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances 6. 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 7. 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 8. Has had radiotherapy within 14 days before the initiation of study treatment |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonie City: Bordeaux | Bordeau | |
France | Institut Gustave Roussy | Villejuif | |
Italy | Fondazione Policlinico Universitario A Gemelli-Rome | Roma | Lazio |
Spain | Instituto de Investigacion Oncologica Vall d'Hebron | Barcelona | |
Spain | START Barcelona_HM Nou Delfos | Barcelona | |
Spain | Hospital Cli´nico San Carlos | Madrid | |
Spain | START Madrid_Hospital Universitario Fundacion Jimenez Diaz | Madrid | |
Spain | START Madrid_Hospital Universitario HM Sanchinarro | Madrid | |
Spain | NEXT Oncology - Hospital Quironsalud Madrid | Pozuelo De Alarcón | Madrid |
United States | University of Colorado Anschutz Medical Center | Aurora | Colorado |
United States | Dana Farber Cancer Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Stefanie Spielman Comprehensive Breast Cancer | Columbus | Ohio |
United States | Mary Crowley Cancer Research | Dallas | Texas |
United States | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | NEXT Virginia | Fairfax | Virginia |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
United States | Angeles Clinic and Research Institute | Los Angeles | California |
United States | Yale University | New Haven | Connecticut |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | University of California, San Francisco | San Francisco | California |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Scorpion Therapeutics, Inc. |
United States, France, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1.1 (Dose Escalation): Number of participants who experience at least 1 Dose Limiting Toxicity (DLT) | First 28 days of treatment | ||
Primary | Part 1.1 (Dose Escalation): Proportion of participants who experience at least 1 DLT during the first 28 days of treatment. | First 28 days of treatment | ||
Primary | Part 1.1 (Dose Escalation): Cmax of STX-478 | 12 months | ||
Primary | Part 1.1 (Dose Escalation): AUC(0-inf) of STX-478 | 12 months | ||
Primary | Part 1.1 (Dose Escalation): AUC(0-t) of STX-478 | 12 months | ||
Primary | Part 1.1 (Dose Escalation): AUC(0-t) of STX-478 | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Change from baseline in ctDNA levels. | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Changes in circulating markers of glucose metabolism as assessed by changes in circulating glycosylated hemoglobin [HbA1c] | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Changes in circulating markers of glucose metabolism as assessed by circulating fasting plasma glucose. | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Changes in circulating markers of glucose metabolism as assessed by circulating C-peptide. | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Objective response rate (ORR). | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Incidence of TEAEs/SAEs = grade 2. | 12 months | ||
Primary | Part 1.1 (Dose Escalation): Frequency of TEAEs according to CTCAE v5.0 criteria. | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): Cmax of STX-478 | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): AUC(0-inf) of STX-478 | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): AUC(0-t) of STX-478 | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): AUC(0-t) of STX-478 | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): Change from baseline in ctDNA levels. | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): Changes in circulating markers of glucose metabolism as assessed by changes in circulating glycosylated hemoglobin [HbA1c] | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): Changes in circulating markers of glucose metabolism as assessed by circulating fasting plasma glucose. | 12 months | ||
Primary | RP2D Selection (Parts 1.2-DS and 2.1): Changes in circulating markers of glucose metabolism as assessed by circulating C-peptide | 12 months | ||
Primary | Parts 1.2-DS and 2.1 (RP2D Selection): ORR | 12 months | ||
Primary | Parts 1.2-DS and 2.1 (RP2D Selection): Frequency counts and percentages of AEs based on MedDRA and CTCAE v5.0 | 12 months | ||
Primary | Parts 1.2-DS and 2.1 (RP2D Selection): Proportion of participants with DLTs. | 12 months | ||
Primary | Parts 1.2-DS and 2.1 (RP2D Selection): Change in ECOG performance status. | 12 months | ||
Primary | Parts 1.2-DE, 1.3, and 2.2 (Dose Expansion): ORR defined as the percentage of participants with partial response or complete response based on RECIST 1.1. | 12 months |
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