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A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination

NCT05525247 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SLC-3010

Intravenous (IV) infusion over 30 minutes on day 1 of each 21-day cycle

COMBINATION_PRODUCT

Gemcitabine

1000 ㎎/㎡ IV infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Sponsors & Collaborators

  • Selecxine

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2026-02-28
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525247 on ClinicalTrials.gov