Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

Part of paid clinical trials in Palo Alto, California.

Sponsor
Fox Chase Cancer Center
Study ID
NCT05274048
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Neratinib Pill — DRUG
    Patients will be enrolled in cohorts of 3 at each dose level of Neratinib (120 mg, 160 mg, 200 mg) daily (days 1 through 21)
  • Fam-Trastuzumab Deruxtecan-Nxki (TDxD) — DRUG
    standard dosing of TDxD (5.4mg/m2) on day 1of a 21 day treatment cycle

Study Details

This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.

Key Dates

Start date
Jun 24, 2022
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neratinib plus TDxD
    Neratinib oral daily days 1-21 plus TDxD on day 1 administered intravenously of a 21 day treatment cycle.

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of TDxD and Neratinib [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94304
Flordeliza Mendoza
[email protected]
Thomas L Holden, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
Marilyn Skinner
[email protected]
Sarbajit Mukherjee, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Namrata Vijayvergia, MD
[email protected]
215-214-1515

Find similar trials in Palo Alto, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Stanford Cancer Center· Palo Alto, CARoswell Park Comprehensive Cancer Center· Buffalo, NYFox Chase Cancer Center· Philadelphia, PA

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