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New treatment option for Solid Tumor
Official title A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04939610
What this study is testing
What is 68Ga-FAP-2286?
68Ga-FAP-2286 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible participants must meet the following . The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified.
- Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any...
- Be ≥ 18 years of age at the time the ICF is signed.
- Have consented to submission of fresh or archival tumor tissue, if available.
- Have adequate organ function confirmed by the following laboratory values obtained within the Screening Period prior to administration of [68Ga]Ga...
You likely can't join if
- Participants who meet any of the following criteria will be excluded from the study. The criteria below apply to participants enrolling in Phase 1 or...
- Active malignancy except for the specific cancer under investigation in this study, ie, participant known to have potentially fatal cancer present...
- History of second malignancy that has been successfully treated, with no evidence of active cancer for 3 years prior to enrollment;
- Surgically cured low-risk tumors, such as early-stage cervical or endometrial cancer, any cancer in situ, or non-melanoma skin cancers; and
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works...
- Symptomatic and/or untreated CNS metastases or leptomeningeal disease or with primary tumor of CNS origin. a. Participants with asymptomatic...
See the full eligibility criteria
Who can join
- Eligible participants must meet the following . The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified.
- Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-specific evaluation.
- Be ≥ 18 years of age at the time the ICF is signed.
- Have consented to submission of fresh or archival tumor tissue, if available.
- Have adequate organ function confirmed by the following laboratory values obtained within the Screening Period prior to administration of [68Ga]Ga FAP 2286 and prior to first cycle of chemotherapy in the combination...
- Have an Eastern Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of ≥ 6 months.
- Have measurable disease per RECIST v1.1 meeting the following criteria:
- At least 1 lesion of ≥ 10 mm in the longest diameter for a non lymph node or ≥ 15 mm in the short axis diameter for a lymph node that is serially measurable according to RECIST v1.1 using conventional CT and/or MRI.
- Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation must show subsequent evidence of substantial size increase to be deemed a target lesion. For Phase 1 only:
- Have a histologically and/or cytologically confirmed advanced/metastatic solid tumor not amenable to treatment with curative intent: a. Tumor must be refractory to or have progressed following prior treatment and have...
- Have cytologically or histologically and radiologically confirmed recurrent or metastatic disease as outlined below: a. Pancreatic Cancer monotherapy group: i. Pancreatic ductal adenocarcinoma (ductal adenocarcinoma and...
- Participant has a histologically and/or cytologically documented diagnosis of HR positive HER2 negative metastatic breast cancer (based on the most recently analyzed tissue sample tested by a local laboratory).
- Participants must have progressed on at least one line of hormone-based therapy (either alone or in combination) and at least one, but not more than two lines of chemotherapy (including cytotoxic, targeted and/or...
- Participant has a histologically and/or cytologically documented diagnosis of HER2 positive metastatic breast cancer (based on the most recently analyzed tissue sample tested by a local laboratory).
- Participant must have progressed on at least two lines of HER2 targeted therapy for metastatic disease. iii. Triple negative breast cancer (TNBC)
- Participant has a histologically and/or cytologically documented diagnosis of TNBC (based on the most recently analyzed tissue sample tested by a local laboratory).
- Participants must have progressed on at least two lines of cytotoxic chemotherapy (including cytotoxic, anti-drug conjugate, targeted therapies and/or IO) for metastatic disease. Key
What rules you out
- Participants who meet any of the following criteria will be excluded from the study. The criteria below apply to participants enrolling in Phase 1 or Phase 2.
- Active malignancy except for the specific cancer under investigation in this study, ie, participant known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving...
- History of second malignancy that has been successfully treated, with no evidence of active cancer for 3 years prior to enrollment;
- Surgically cured low-risk tumors, such as early-stage cervical or endometrial cancer, any cancer in situ, or non-melanoma skin cancers; and
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Symptomatic and/or untreated CNS metastases or leptomeningeal disease or with primary tumor of CNS origin. a. Participants with asymptomatic, previously treated CNS metastases are eligible provided they have been...
- Received anticancer treatment with chemotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of...
- Received prior radiopharmaceutical therapy (eg, radium 223 223Ra-dichloride, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617, actinium 225 [225Ac]Ac PSMA-617, etc.) or prior EBRT to more...
- Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection/infusion of [68Ga]Ga-FAP-2286 or [177Lu]Lu FAP 2286.
- Ongoing adverse effects from anticancer treatment NCI-CTCAE v5.0 (or higher) Grade 1, with the exception for alopecia and vitiligo. Exclusion criteria 6 and 7 are removed with Protocol Amendment 7. 8. Impaired cardiac...
- Clinically significant and/or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association \> Class 2), uncontrolled hypertension, clinically significant arrhythmia, or...
- Corrected QT interval (Fridericia's formula) \> 450 msec for males or \> 470 msec for females at Screening; or
- Acute coronary syndrome or acute myocardial infarction ≤ 6 months prior to administration of [177Lu]Lu FAP 2286. 9\. Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Adelaide, South Australia, Australia
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.