A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination With Various Anticancer Therapies in Patients With Advanced Solid Tumors

Selecxine1 site in 1 country420 target enrollmentDecember 21, 2022

ConditionsAdvanced Solid Tumor

InterventionsSLC-3010 Gemcitabine

DrugsSLC-3010

Overview

Phase: Phase 1
Intervention: SLC-3010
Conditions: Advanced Solid Tumor
Sponsor: Selecxine
Enrollment: 420
Locations: 1
Primary Endpoint: Occurrence of DLTs
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study, evaluating the safety, tolerability, pharmacokinetic, preliminary anti-tumor activity, and effects on pharmacodynamic markers following administration of SLC-3010 as monotherapy and in combination with gemcitabine, in patients with various advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

December 21, 2022

End Date

January 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Selecxine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all the following inclusion criteria to be eligible for enrollment into the study:
•Histologically or cytologically-documented solid tumors that are inoperable locally advanced, metastatic, or recurrent:
•Part 1 Dose Escalation: Patients with any solid tumor who have progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
•Part 2: Dose Expansion: Patients must have received at least one prior line of standard therapy in recurrent/metastatic setting and for whom standard life-prolonging therapies are either not available or are not qualified to receive such therapies. Additional general and tumor specific inclusion and exclusion criteria will apply.
•Patients who have at least one measurable lesion, as defined by RECIST v1.
•Adult male or female patients ≥18 years of age on day of signing the informed consent form (ICF) or follow local regulatory requirement if the legal age for consenting for study participation is more than 18 years.
•Patients who are able and willing to provide written informed consent and are willing and able to comply with all study procedures.
•Patients with life expectancy of ≥3 months.
•Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
•Patients who demonstrate adequate organ function as defined.

Exclusion Criteria

•Individuals who meet any of the following exclusion criteria will not be eligible to participate:
•Prior history of or active malignant disease other than that being treated in this study.
•Exceptions: (i) Malignancies that were treated curatively and have not recurred within the past 2 years, or (ii) Completely resected basal cell carcinoma and squamous cell carcinoma of the skin, or (iii) Completely resected carcinoma in situ of any type.
•Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/ or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study drug. Note: patients with an incidental finding of an isolated lesion \<1 cm in diameter may be eligible if the lesion does not require treatment per investigator judgment. Eligible patients must be neurologically asymptomatic and without corticosteroids treatment for at least 2 weeks prior to start of first dose of study treatment.
•Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy, or any immunosuppressive therapy within 7 days prior to first dose of study drug. Topical (\<class III), inhaled, nasal, and ophthalmic steroids are allowed.
•Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
•History of Grade 3 or higher immune mediated AEs that were considered drug related to prior immunotherapy (e.g., checkpoint inhibitors, co-stimulatory agents).
•Infection with HIV-1 or HIV-
•Active hepatitis B (hepatitis B virus \[HBV\] surface antigen positive), hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid). Patients with prior history of HBV are eligible if quantitative polymerase chain reaction (PCR) for HBV DNA is negative. Patients with HCV with undetectable virus after treatment, and those who have minimal viral load (\<20 IU/ml) at screening and who are being treated with HCV therapy during the full study period are eligible.
•Has an active infection requiring systemic therapy

Arms & Interventions

Monotherapy

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle

Intervention: SLC-3010

Gemcitabine combination

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle Gemcitabine 1000 ㎎/㎡ Intravenous infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Intervention: SLC-3010

Gemcitabine combination

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle Gemcitabine 1000 ㎎/㎡ Intravenous infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Intervention: Gemcitabine