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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768139
Other study ID # STX-478-101
Secondary ID 2023-000442-4120
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 17, 2023
Est. completion date February 28, 2029

Study information

Verified date May 2024
Source Scorpion Therapeutics, Inc.
Contact For questions concerning enrollment
Phone Please email:
Email clinicaltrials@scorpiontx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
STX-478
STX-478 is a second generation, mutant-selective, oral PI3Ka small molecule allosteric inhibitor.
Fulvestrant
Fulvestrant will be administered according to local labeling.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Scorpion Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain, 

Outcome

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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