A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Orlando, Florida.

Sponsor
NextCure, Inc.
Study ID
NCT06792552
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • Fallopian Tube Cancer
  • NSCLC (Non-small Cell Lung Cancer)
  • Papillary Renal Cell Carcinoma (Prcc)
  • Platinum Resistant Ovarian Cancer
  • Primary Peritoneal Cancer
  • Renal Cell Carcinoma (RCC)
  • Uterine Serous Carcinoma (USC)

Eligibility Criteria

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

Interventions

  • SIM0505 for injection — DRUG
    Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.
  • SIM0505 for injection — DRUG
    Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505

Study Details

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors

Key Dates

First listed
Jan 24, 2025
Start date
Feb 26, 2025
Status verified
Jul 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
738 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIM0505 mono dose escalation
    Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.
  • Experimental: SIM0505 mono dose optimization - PROC
    Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in PROC.
  • Experimental: SIM0505 mono dose optimization - RCC
    Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in RCC.
  • Experimental: SIM0505 mono dose optimization - USC
    Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in USC.
  • Experimental: SIM0505 mono dose optimization - NSCLC
    Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in NSCLC.

Primary Outcome Measure

dose escalation: Dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute (SCRI) - Lake NonaOrlandoFlorida32827-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
University Medical Center of New Orleans LSU-LCMC Health Cancer CenterNew OrleansLouisiana70112-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-
Icahn School of Medicine at Mount SinaiNew YorkNew York10128-
Sarah Cannon Research Institute (SCRI) - NashvilleNashvilleTennessee37203-
UT Health San Antonio - Mays Cancer CenterSan AntonioTexas78229-

Find similar trials in Orlando, FL

By research site
Sarah Cannon Research Institute (SCRI) - Lake Nona· Orlando, FLEmory Winship Cancer Institute· Atlanta, GAUniversity Medical Center of New Orleans LSU-LCMC Health Cancer Center· New Orleans, LADana-Farber Cancer Institute· Boston, MAHackensack University Medical Center· Hackensack, NJRoswell Park Cancer Institute· Buffalo, NY

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