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Study Summary
This trial is studying a new molecule, DF1001, that targets the activation signals of natural killer (NK) cells and T-cells to receptors on cancer cells. The trial will occur in two phases, with the first phase testing different doses of DF1001 on patients with various types of solid tumors to see what is the best dose. The second phase will use the best dose from the first phase on patients with either selected solid tumors, or solid tumors expressing high levels of HER2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My liver is working well.I have been treated with trastuzumab, pertuzumab, and a HER2-targeting ADC.My cancer shows a low level of HER2 protein.My cancer has worsened after one chemotherapy treatment.My cancer has worsened despite treatment targeting PD-1/PD-L1.I have had a recent biopsy of my tumor.I have hormone receptor-positive cancer and it worsened despite hormone therapy.My cancer can be seen on scans, but it doesn't need to be measurable.I am eligible for nivolumab treatment for my cancer.I've had a first treatment with platinum, fluoropyridine, and an anti-PD-1.My tumor is HER2 low based on specific tests.My cancer progressed within 6 months while on anti PD-(L)1 therapy.My heart's pumping ability is significantly reduced.I've had chemotherapy and PD-1/PD-L1 inhibitors for bladder cancer.I have mild side effects from previous treatments, but hair loss and mild nerve issues are okay.My cancer is advanced or has spread, and standard treatments have failed or don't exist.My cancer shows HER2 presence through a special staining test.I have received only one treatment for my cancer after it spread.My cancer has no standard treatment left, or treatments have failed, and I haven't had taxane in the last 6 months.I know my cancer's mutation status and have either tried and progressed, couldn't tolerate, or can't use standard treatments.My tumor is HER2 positive.My cancer has been tested and shows HER2 activity.I have not taken any drugs recently that are not allowed in the trial, but I have previously taken HER2-targeting treatments with the required break period.I am not currently on any cancer treatments, major surgery, steroids, or investigational drugs.I haven't had cancer other than skin or early cervical cancer in the past 3 years.I take medication for chest pain due to heart problems.My cancer has a known increase in the ERBB2 gene.My cancer tests show high levels of HER2.My cancer is a type of bladder cancer that has spread.My cancer progressed within 6 months while on anti PD-(L)1 therapy.I have severe allergies to certain medications or uncontrolled asthma.You have a known history of alcohol or drug abuse.My cancer has worsened after one chemotherapy treatment.I have a serious heart valve problem.My lung cancer is at an advanced stage and tests show HER2 presence without erbb2 amplification.My lung cancer is at an advanced stage and tests show an increase in the erbb2 gene.I am mostly active and my doctor thinks I have at least 3 months to live.My blood counts are within a healthy range.I am eligible for nab-paclitaxel for my metastatic breast cancer and haven't had taxanes in the last 6 months.I am legally unable to make my own medical decisions.I have had a recent tumor biopsy.My breast cancer is confirmed by lab tests and is advanced.My condition worsened after my first treatment.I have a serious heart condition.I need extra oxygen or have severe shortness of breath at rest due to my advanced cancer.I haven't needed strong immune system medications for a long condition, except for skin color loss, in the last 3 years.My cancer has worsened after my last treatment.My cancer does not show high levels of HER2 protein.My cancer, not breast, gastric, or esophageal, worsened after HER2 treatment.I have a serious heart rhythm problem.I have or had cancer spread to my brain or spinal cord.I am unable to sign the consent form or follow the study's requirements.I've had a first treatment with specific drugs and trastuzumab for my cancer.I can provide a tissue sample if my cancer is HER2 positive.I have undergone at least one standard treatment for my condition.I have a fast heartbeat (over 100 beats per minute) that is not under control.I am 18 years old or older.My kidney function is normal.Standard treatments have failed me, and I haven't received nivolumab before.My first treatment is for advanced triple-negative breast cancer.My cancer has worsened after my last treatment.My cancer came back or got worse after platinum chemotherapy.I do not have significant infections like HIV or active hepatitis.My cancer progressed after treatment with anti-PD-(L)1 therapy.My cancer is advanced and cannot be removed by surgery.My esophageal cancer cannot be removed by surgery and may have spread.My cancer is growing quickly.I do not have any major health issues that would stop me from joining the study.I have had an organ or stem cell transplant.
- Group 1: Combination Therapy with DF1001 and Nivolumab
- Group 2: Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer
- Group 3: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion
- Group 4: Combination Therapy with DF1001 and Nab-paclitaxel
- Group 5: Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC
- Group 6: Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion
- Group 7: Monotherapy DF1001 Expansion in Gastric Cancer
- Group 8: Monotherapy DF1001 Dose Escalation
- Group 9: Monotherapy DF1001 Safety/PK/PD Expansion
- Group 10: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)
- Group 11: Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification
- Group 12: Monotherapy DF1001 Expansion in Urothelial Bladder Cancer
- Group 13: Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer
- Group 14: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)
- Group 15: Monotherapy DF1001 Expansion in NSCLC
- Group 16: Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC
- Group 17: Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer
- Group 18: Monotherapy DF1001 Expansion in Esophageal Cancer
- Group 19: Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC
- Group 20: Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)
- Group 21: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)
- Group 22: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the main intent of this clinical research?
"The primary endpoint of the clinical trial is to quantify any dose-limiting toxicities over a 90 day period following completion. Secondary endpoints are assessing the safety profile, progression free survival rate and serum concentration levels when DF1001 is used in combination with nivolumab via National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 as well as measuring blood samples taken at various time points on study."
How many participants is the clinical trial accommodating?
"A total of 220 volunteers need to be enlisted in this research from two distinct locations; University of Kansas Medical Center Research Institute, Inc. in Westwood, and University of Southern California located in Los Angeles. Those who meet the predetermined criteria can join the study."
Is enrollment for this research project still available?
"Absolutely, clinicaltrials.gov has verified that this research is currently enrolling participants. It was initially advertised on November 11th 2019 and updated recently on March 21st 2022; the investigation necessitates 220 candidates from 17 medical centres."
What other experiments have utilized DF1001 to assess its efficacy?
"At the moment, DF1001 is being clinically tested in 1504 trials with 298 of those studies in their final phase. While most are situated within Shanghai, there are a total 79770 worldwide locations for clinical trial involving this drug."
How many locations are currently conducting this research trial?
"This particular medical trial is currently enrolling patients from 17 distinct locations, including Westwood, Los Angeles and Detroit. To minimise travel requirements for those who join the study, prospective participants should select their nearest site."
What is the predominant application of DF1001 in clinical contexts?
"DF100 is a medication regularly prescribed to patients with inoperable melanoma. It may also be beneficial for those experiencing squamous cell carcinoma, high risk of recurrence, or disease progression."
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