Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID04827810

A Phase I Study of Intravenous Gamitrinib for Patients With Advanced Cancer to Assess Safety and Pharmacokinetics

Led by Fox Chase Cancer Center · Updated on 2025-06-29

42

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

F

Fox Chase Cancer Center

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and appropriate dosing of gamitrinib, a small molecule mitochondrial-targeted Hsp90 inhibitor, in patients with advanced cancers. This first-in-human, phase I, open-label study aims to identify dose-limiting toxicities and the maximum tolerated dose in patients with advanced solid tumors or lymphoma. The study builds on preclinical evidence showing gamitrinib's unique mechanism and preliminary safety profile. Gamitrinib is given as a one-hour intravenous infusion once weekly in 28-day treatment cycles. The study includes a dose-escalation phase with up to 36 patients receiving increasing doses starting at 10 mg, following a 3+3 design. Following dose escalation, up to six patients will receive the maximum tolerated dose in a dose-expansion phase to explore pharmacodynamic effects through tumor biopsies taken before and during treatment. Participants will undergo regular assessments including safety monitoring, pharmacokinetic blood tests, and tumor biopsies for pharmacodynamic evaluation. Researchers will measure the maximum tolerated dose, recommended dose for phase II, and pharmacokinetic parameters such as peak concentration and clearance. The trial lasts up to seven years, covering treatment and follow-up to assess safety, pharmacodynamics, and any anti-tumor activity.

CONDITIONS

Brief Title

A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of advanced cancer refractory to standard of care therapy or no available standard treatment
  • Solid tumors or lymphoma with measurable or evaluable disease as per RECIST v1.1 or RECIL 2017
  • For dose expansion, at least one measurable disease site and willingness to undergo tumor biopsies
  • Discontinuation of prior cancer therapies for at least 14 days (28 days for certain drugs) before treatment start
  • Age over 18 years
  • ECOG performance status of 0 to 2
  • Normal organ and marrow function as defined by blood counts and chemistry
  • Negative pregnancy test for women of childbearing potential within 7 days before treatment
  • Ability to understand and sign informed consent
  • Use of effective contraception for men and women during and 90 days after treatment completion
Not Eligible

You will not qualify if you...

  • Symptomatic brain metastases; asymptomatic treated brain metastases allowed after 28 days post-treatment
  • Participation in another therapeutic clinical trial
  • Uncontrolled hypertension (>150/100 mm Hg despite treatment)
  • Active bacterial, fungal, or viral infection requiring intravenous treatment
  • Known HIV/AIDS-related illness
  • History within 6 months of serious heart or vascular conditions
  • Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 years

Participants receive intravenous gamitrinib once weekly to assess safety, pharmacokinetics, and determine the maximum tolerated dose.

Weekly visits for dosing and assessments

Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

A

Anthony Olszanski, MD

M

Matthew Zibelman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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Published Research Related To This Trial

Feasibility and safety of targeting mitochondria for cancer therapy - preclinical characterization of gamitrinib, a first-in-class, mitochondriaL-targeted small molecule Hsp90 inhibitor.

Umar Hayat, Gary T Elliott, Anthony J Olszanski...

https://pubmed.ncbi.nlm.nih.gov/35129069