DF6215 in Advanced Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to determine the safety of an investigational drug called DF6215 in people who have a locally advanced or metastatic solid tumor. A locally advanced solid tumor is cancer that is confined to the area where it started but cannot be removed by surgery. A metastatic solid tumor is cancer that has spread from the place where it began to another part of the body. Researchers aim to evaluate the levels of DF6215 in the blood and safety of DF6215, as well as how people with certain types of solid tumor cancers respond to the drug. DF6215 will be given intravenously (via injection into the vein).

Eligibility

* Signed written informed consent
* Male or female patients aged ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
* Adequate hematological function

* Signed written informed consent
* Male or female patients aged ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
* Adequate hematological function
* Adequate cardiac function
* Effective contraception
* Histologically or cytologically proven locally advanced or metastatic solid tumor, for which no standard therapy exists, or standard therapy has failed
* Evidence of objective disease (but participation does not require a measurable lesion)
* Archived tumor biopsy. If archival tissue is unavailable, a fresh tumor biopsy is required, obtained within the screening window.
* Histologically or cytologically proven locally advanced or metastatic solid tumor from the following list, where standard therapy does not exist or has failed:
* Melanoma
* HPV-positive advanced malignancies
* Ovarian cancer
* Head and neck cancer
* Lung cancer (non-small-cell lung cancer \[NSCLC\])
* Renal cell carcinoma (RCC)
* Other tumor types may be eligible after discussion with the Sponsor medical monitor
* Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
* A fresh tumor biopsy must be obtained during the screening window and on-treatment
* Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
* A fresh tumor biopsy must be obtained during the screening window and on-treatment
* Patients receiving chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), major surgery, or receiving another therapeutic agent within 28 days before the start of study drug or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter
* Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy \[except for palliative bone-directed radiotherapy\], immune therapy, or cytokine therapy \[except for erythropoietin\]), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of treatment or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter. Short-term administration of systemic steroids (eg, for allergic reactions or the management of immune-related adverse events \[irAEs\]) is allowed.
* Note: Patients receiving bisphosphonate or denosumab are eligible, provided treatment was initiated at least 14 days before the first dose of DF6215
* Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, low-grade prostate cancer (Gleason score ≤ 6 and must be Stage I or II), or cervical carcinoma in situ
* Life expectancy of less than 3 months
* Patients with brain metastases are excluded, unless all of the following criteria are met:
* Central nervous system (CNS) lesions are asymptomatic and previously treated
* Patient does not require ongoing daily steroid treatment for replacement for adrenal insufficiency (except ≤ 10 mg prednisone \[or equivalent\])
* Imaging demonstrates stable disease 28 days after last treatment
* Receipt of any organ transplant, including autologous or allogeneic stem-cell transplantation
* Pregnancy or lactation during the study

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Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

DF6215-001: A Phase 1/1B, First-in-human, Multi-Part, Open-Label study to investigate the safety tolerability, pharmacokinetics, biological and clinical activity of Df6215 in patients with advanced solid tumors

Study Details

Disease Type/Condition

Brain and Nervous System, Breast, Cervix, Colon, Lung, Other Female Genital, Ovary, Pancreas, Prostate

Principal Investigator

Hafez, Navid

Co-Investigators

Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00003088

ClinicalTrials.gov ID

NCT06108479

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org