A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies. Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s). Estimated enrollment is 15 subjects per Sub-Protocol.

Key facts

Study ID

NCT03471286

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

2

Starts

2019-06-06

Expected to finish

2021-07-30

Last updated by the study team

2021-08-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have biopsy-proven solid tumor that is eligible for elective surgical resection, disease does not require immediate therapy, and there is NO approved/ standard therapy available that is shown to prolong overall survival.
• ECOG performance status of 0 or 1.
• Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
• Willing to provide tissue and blood samples for research.

You may not qualify if…

• The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma, Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III rectal cancer.
• Any active malignancy within 3 years prior, except: Adequately treated basal cell or squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1) treated with curative intent.
• Any uncontrolled intercurrent illness, including but not limited to: Symptomatic congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social situations that would limit compliance with study requirements, or Ongoing or active infection.
• Any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s).
• Unwilling or unable to follow the study schedule.
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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