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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Selecxine
Study ID
NCT05525247
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SLC-3010 — DRUG
    Intravenous (IV) infusion over 30 minutes on day 1 of each 21-day cycle
  • Gemcitabine — COMBINATION_PRODUCT
    1000 ㎎/㎡ IV infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Study Details

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.

Key Dates

Start date
Dec 21, 2022
Status verified
Feb 2023
Primary completion
Feb 28, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy
    SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle
  • Experimental: 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

Primary Outcome Measure

Occurrence of DLTs [ Time Frame: 30 days after last dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Selecxine Investigator siteSarasotaFlorida34232-
Selecxine Investigator siteDetroitMichigan48201-
Selecxine Investigator siteOklahoma CityOklahoma73104-

Find similar trials in Sarasota, FL

By research site
Selecxine Investigator site· Sarasota, FLSelecxine Investigator site· Detroit, MISelecxine Investigator site· Oklahoma City, OK

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