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 Sacramento, California.

Sponsor
Marengo Therapeutics, Inc.
Study ID
NCT05592626
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Neoplasm
  • Advanced Solid Tumors
  • Carcinoma
  • Colorectal Cancer
  • Epstein-Barr Virus Infections
  • Genital Neoplasm, Female
  • Lung Neoplasm
  • NSCLC (Non-small Cell Lung Cancer)
  • 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
  • Irinotecan (Camptosar) — COMBINATION_PRODUCT
    solution, intravenous infusion
  • Docetaxel (Taxotere) — COMBINATION_PRODUCT
    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 and in combination with chemotherapy 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
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Phase 1: Advanced Solid Tumors
    Dose Escalation; Intervention: Drug: STAR0602, Invikafusp alfa
  • 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, Invikafusp alfa

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 (13)

FacilityCityStateZIPSite coordinators
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
AdventHealth CelebrationCelebrationFlorida34747
Guru Sonpavde, MD
407 303 2024
Guru Sonpavde, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
The University of Kansas Cancer CenterKansas CityKansas66160
Weijing Sun, MD
[email protected]
Weijing Sun, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of HealthBethesdaMaryland20892
Melissa Walker
[email protected]
Stephanie Hicks
[email protected]
James Gulley, MD, PhD (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)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Asrar Alahmadi, MD
[email protected]
Asrar Alahmadi, 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
Pia Morelli, MD, PhD
[email protected]
Pia Morelli, MD, PhD (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-
University of Wisconsin- MadisonMadisonWisconsin53792
Vincent Ma, MD
[email protected]
Vincent Ma, MD (PRINCIPAL_INVESTIGATOR)

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