A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Loma Linda, California.

Sponsor
Marengo Therapeutics, Inc.
Study ID
NCT05592626
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Abdominal Neoplasm
  • Advanced Solid Tumors
  • Carcinoma
  • Epstein-Barr Virus Infections
  • Genital Neoplasm, Female
  • Lung Neoplasm
  • Neoplasms
  • Neoplasms by Site
  • Papillomavirus Infection
  • Urogenital Neoplasms
  • Vulvar Diseases
  • Vulvar Neoplasms

Eligibility Criteria

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

Interventions

  • STAR0602 — DRUG
    solution, intravenous infusion

Study Details

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Key Dates

Start date
Jan 4, 2023
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Phase 1: Advanced Solid Tumors
    Dose Escalation; Intervention: Drug: STAR0602
  • Experimental: Phase 2: Advanced Solid Tumors
    Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

Primary Outcome Measure

Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1 [ Time Frame: Cycle 1 (Cycle length= 28 days) ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Loma Linda University Cancer CenterLoma LindaCalifornia92354
John Shin, MD
[email protected]
John Shin, MD (PRINCIPAL_INVESTIGATOR)
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Tianhong Li, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Julia Etchart
[email protected]
Jason Henry, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth CelebrationCelebrationFlorida34747
Guru Sonpavde, MD
407 303 2024
Guru Sonpavde, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Marijo Billusic, MD
307-243-1543
Marijo Billusic, MD (PRINCIPAL_INVESTIGATOR)
The University of Kansas Cancer CenterKansas CityKansas66160
Weijing Sun, MD
[email protected]
Weijing Sun, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of HealthBethesdaMaryland20892
Victoria Jeffers
[email protected]
240-858-3783
James Gulley, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Joanne Charles
617-632-6571
Ann Silk, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Ryan Sullivan, MD
(617) 643-3614
Ryan Sullivan, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Victoria LaBush
313-576-8411
Wasif Saif, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065
Luisa Belfoiore
[email protected]
(646) 888-4247
Gopa Iyer, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Kai He, MD
6143664139
Kai He, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences, Stephenson Cancer CenterOklahoma CityOklahoma73104
Amanda Anundson
[email protected]
Abdul R Naqash, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)NashvilleTennessee37203
Meredith Pelster, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas, MD Anderson Cancer CenterHoustonTexas77030
Stephane Champiat, MD (PRINCIPAL_INVESTIGATOR)
UT Health Mays Cancer CenterSan AntonioTexas78229
Sheniell Granato
[email protected]
210-450-1950
Sukeshi Patel Arora, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Ariana Dumenigo Jimenez
[email protected]
Joe Lograsso
[email protected]
Diane Tseng, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin- MadisonMadisonWisconsin53792
Vincent Ma, MD
[email protected]
Vincent Ma, MD (PRINCIPAL_INVESTIGATOR)

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