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New treatment option for Metastatic Colorectal Cancer (Mcrc)
Official title PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
ClinicalTrials.gov ID: NCT05286814
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metastatic colorectal cancer (mcrc).
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
- Background: One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- - All Cohorts
- Participants must have a documented diagnosis of one of the following cancers:
- Metastatic colorectal cancer (mCRC)
- Intrahepatic cholangiocarcinoma (ICC)
- Adrenocortical carcinoma (ACC) with liver dominant disease
You likely can't join if
- Exclusion Criteria- All Cohorts Participants who are receiving any other investigational agents.
- Participants who have previously received rIL-12.
- Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:
- diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
- participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal...
- administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or...
See the full eligibility criteria
Who can join
- - All Cohorts
- Participants must have a documented diagnosis of one of the following cancers:
- Metastatic colorectal cancer (mCRC)
- Intrahepatic cholangiocarcinoma (ICC)
- Adrenocortical carcinoma (ACC) with liver dominant disease
- Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than...
- mCRC: FOLFOX or FOLFIRI
- ICC: GemOx or FOLFOX
- ACC: GemOx
- Age \>= 18 years.
- Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical...
- All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study...
- Nursing (including breastfeeding) participants must agree to discontinue nursing.
- Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C/A/P multiphase) amenable to placement of the HAIP.
- Participant must sign the informed consent form to participate in this study.
- HIV-positive participants may be considered for this study only if they have an undetectable viral load.
- Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, "Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors".
- Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage. -Metastatic Colorectal Carcinoma
- Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).
- Participants must have measurable liver metastatic disease.
- Participants must have received 1st line systemic chemotherapy.
- ECOG performance status \<= 1.
- Participants must have adequate organ and marrow function as defined below:
- leukocytes \> 3,000/mcL
- absolute neutrophil count \> 1,500/mcL
- platelets \> 90,000/mcL
- hemoglobin \> 8 g/dL
- total bilirubin \< 1.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \> 60 mL/min/1.73 m2. -Intrahepatic Cholangiocarcinoma
- Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available...
- Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.
- Participants must have radiographically measurable disease.
- Disease must be considered unresectable at the time of preoperative evaluation.
- Participants must have received 1st line systemic chemotherapy.
- ECOG performance status \<=1.
- Participants must have adequate organ and marrow function as defined below:
- leukocytes \>= 2,000/ mm\^3
- absolute neutrophil count \> 1,500/mcL
- platelets \>= 75,000/ mm\^3
- hemoglobin \> 8 g/dL
- total bilirubin \< 1.5 mg/dl
- creatinine \<= 1.5 mg/dl -Adrenocortical Carcinoma
- Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as "adrenocortical cancer".
- Participants must have received at least one line of systemic chemotherapy.
- Participants must have measurable liver metastatic disease.
- ECOG performance status \<= 1.
- Participants must have adequate organ and marrow function as defined below:
- leukocytes \> 3,000/mcL
- absolute neutrophil count \> 1,500/mcL
- platelets \> 90,000/mcL
- hemoglobin \> 8 g/dL
- total bilirubin \< 1.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) \< 3 X institutional upper limit of normal
- creatinine \< 2 X institutional upper limit of normal
What rules you out
- Exclusion Criteria- All Cohorts Participants who are receiving any other investigational agents.
- Participants who have previously received rIL-12.
- Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:
- diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
- participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \<= 10 mg of prednisone or equivalent per day;
- administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.
- History of organ transplant, except for transplants that do not require immunosuppression.
- History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).
- Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of...
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke \ = NYHA III) or serious cardiac arrhythmia requiring medication.
- All conditions associated with significant necrosis of nontumor-bearing tissues.
- Esophageal or gastroduodenal ulcers \< 6 months prior to treatment.
- Active ischemic bowel disease.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.
- Prior radiation to liver.
- Participants with active Hepatitis B or C infection.
- Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).
- Any condition, including the presence of laboratory abnormalities and/or insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the...
- Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.
- Participants with a history of MSI-high results who need to be treated with check-point inhibitors.
- Prior treatment with FUDR. Exclusion Criteria-Intrahepatic Cholangiocarcinoma -Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed...
- Prior treatment with FUDR.
- Diagnosis of sclerosing cholangitis.
- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Exclusion Criteria-Adrenocortical Carcinoma
- Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump...
- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).
- Diagnosis of sclerosing cholangitis.
- Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.
- Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.