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
Apply to this trial

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

First listed
Oct 24, 2022
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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