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
Apply to this trial

Conditions

  • Advanced Solid Tumors

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

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

Study Design

Enrollment
414 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 - Ovarian
    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 ovarian cancer.
  • Experimental: SIM0505 mono dose optimization - Renal
    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 renal cancer.
  • 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 uterine cancer.
  • 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 lung cancer.

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
Ingrid Acker, BSN,RN,CCRP
[email protected]
(904) 380 - 2410
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30322
Emma Barton-Judson
[email protected]
404-778-2695
Beryl Manning-Geist, MD (PRINCIPAL_INVESTIGATOR)
University Medical Center of New Orleans LSU-LCMC Health Cancer CenterNew OrleansLouisiana70112
Shou-Ching Tang, MD
[email protected]
504-210-2666
Shou-Ching Tang, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Joyce Liu, MD
[email protected]
617-632-5269
Joyce Liu, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Miguel GonzalezVelez, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Kimberly Benczkowski
[email protected]
716-845-1300
Emese Zsiros, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10128
Neha Kumarley
[email protected]
212-824-7859
Dmitriy Zamarin, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI) - NashvilleNashvilleTennessee37203
SCRI Main Email
[email protected]
615.329.7274
Erika Hamilton, MD (PRINCIPAL_INVESTIGATOR)
UT Health San Antonio - Mays Cancer CenterSan AntonioTexas78229
Adrianna Amaya
[email protected]
210-450-1794
Daruka Mahadevan, MD (PRINCIPAL_INVESTIGATOR)

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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