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New treatment option for Sarcoma
Official title A Study of CRD3874-SI in People With Solid Tumors
ClinicalTrials.gov ID: NCT06021626
What this study is testing
What is CRD3874?
CRD3874 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for sarcoma.
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
- This study will test the safety of a study drug called CRD3874-SI. The researchers will test different doses of CRD3874-SI to find the highest dose that causes few or mild side effects in participants.
- Phase 1: an early, usually small safety study
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
- Male or female age ≥ 18 years at the time of informed consent.
- Be capable, willing, and able to provide written informed consent.
- Be willing to comply with clinical trial instructions and requirements, including tumor biopsies (if feasible and required per protocol).
- Patients must have a locally advanced or metastatic cancer, a malignant solid tumor that has progressed on at least one line of systemic therapy or...
- In the dose escalation phase study patients with the following tumor types will be eligible: Of note patients who declined or were intolerable of...
You likely can't join if
- Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene...
- Evidence of clinically significant immunosuppression such as the following:
- Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
- Concurrent opportunistic infection
- Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior...
- Current use of immunosuppressive medication, EXCEPT for the following: I. Intranasal, inhaled, ocular, topical steroids, or local steroid injection...
See the full eligibility criteria
Who can join
- Male or female age ≥ 18 years at the time of informed consent.
- Be capable, willing, and able to provide written informed consent.
- Be willing to comply with clinical trial instructions and requirements, including tumor biopsies (if feasible and required per protocol).
- Patients must have a locally advanced or metastatic cancer, a malignant solid tumor that has progressed on at least one line of systemic therapy or for which no standard treatment is available, the participant is...
- In the dose escalation phase study patients with the following tumor types will be eligible: Of note patients who declined or were intolerable of standard of care systemic therapy will be considered in all dose...
- Head and neck squamous cell carcinoma (HNSCC)
- Participants must have histologically or cytologically confirmed recurrent and/or metastatic HNSCC and must have received 1-2 prior lines of systemic anti-cancer therapy including a checkpoint inhibitor (patients...
- HPV positive (p16 IHC positive or HPV RNA ISH positive), PD-L1 CPS score high (≥1)
- HPV negative (p16 IHC negative or HPV RNA ISH negative), PD-L1 CPS score high (≥1)
- Adenoid cystic carcinoma (ACC)
- Participants must have histologically or cytologically confirmed recurrent and/or metastatic ACC (cancers arising from non-salivery gland primary sites are eligible) and may have received none or up 2 prior lines of...
- Merkel cell carcinoma (MCC)
- Participants must have histologically or cytologically confirmed recurrent and or metastatic MCC and must have received at least one but no more than 3 prior lines of systemic anti-cancer therapy including a checkpoint...
- Monotherapy alone
- Radiation therapy
- Patients will receive palliative radiation therapy to a tumor site if they have at least one other site of measureable disease that can be chosen as the target lesion to assess response to investigational therapy.
- Sarcoma that has demonstrated clinical benefit or an objective response to immune checkpoint blockade or sarcoma subtypes that are considered immunogenic subtypes including but not limited to undifferentiated...
- Melanoma
- Uveal Melanoma
- Participants must have histologically or cytologically confirmed recurrent and/or metastatic uveal melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including...
- Mucosal and Acral melanoma
- Participants must have histologically or cytologically confirmed recurrent and/or metastatic mucosal or acral melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including...
- Non small cell lung cancer
- Participants must have histologically or cytologically confirmed locally advanced/metastatic non-small cell lung cancer with prior exposure to immune checkpoint inhibition and received at least one but no more than 2...
- Participants must have histologically or cytologically confirmed locally advanced/metastatic sarcoma and must have received at least one but no more than 2 prior lines of systemic anti-cancer therapy. Patients will...
- Adequate performance status: ECOG 0 or 1/KPS 100-70%.
- Life expectancy of at least three months after the first CRD3874 infusion, according to the Investigator's opinion
- Presence of measurable disease per RECIST v1.1.Target lesion(s) must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that...
- In the dose expansion phase , participants must agree to have a pretreatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom the associated procedure would result...
- In the dose expansion phase , participants must agree to on-treatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the...
- Female subject of childbearing potential (defined as a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive...
- Adequate organ function determined within 14 days of treatment initiation, defined as follows:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,000/mm\^3 (1.0 x 10\^9/L)
- Platelet count ≥ 100,000/mm3 (100 x 10\^9 /L)
- Serum bilirubin ≤ 1.2x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin level \> 1.2x ULN
- Aspartate aminotransferase (AST) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases
- Alanine aminotransferase (ALT) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases
- Albumin ≥ 2.5mg/dL.
- Calculated creatinine clearance (CrCl) ≥ 50 mL/min by Cockcroft-Gault formula or CKD-EPI 2021
- International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended...
- Activated partial thromboplastin time (aPTT) ≤ 1.5x ULN unless participant is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants
- Left ventricular ejection fraction (LVEF) \> 50%, as measured by echocardiogram (2D-ECHO) or multi-gated acquisition scan (MUGA)
What rules you out
- Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG), (NCI CTCAE v5.0 Grade ≥ 3)
- Evidence of clinically significant immunosuppression such as the following:
- Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
- Concurrent opportunistic infection
- Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. In the setting of non-immune mediated indications for...
- Current use of immunosuppressive medication, EXCEPT for the following: I. Intranasal, inhaled, ocular, topical steroids, or local steroid injection (e.g., intraarticular injection) II. Systemic corticosteroids at...
- Prior organ transplantation, including allogenic stem-cell transplantation. Consideration will be given to allow patients with a history of autologous transplantation enroll if they are at least 5 years beyond the...
- History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of...
- Systemic antibiotics received ≥ 7 days prior to the first dose of study drugs.
- Uncontrolled medical condition including current active infection requiring systemic therapy or symptomatic congestive heart failure within 6 months that in the investigators opinion compromise the ability of the...
- Inability to comply with protocol required procedures
- Resting QTc interval by Friderica's formula ≥ 470 ms on a 12-lead electrocardiogram (ECG) for males and females
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of...
- Has had prior chemotherapy or targeted small molecule therapy within 3 weeks, anti-cancer monoclonal antibody (mAb) within 4 weeks or OR 5 half-lives, if shorter, or radiation therapy within 2 weeks prior to the first...
- Note: Alopecia or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
- Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy
- Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment.
- History of unstable or deteriorating cardiovascular disease within the previous 6 months prior to screening including but not limited to the following:
- Unstable angina or myocardial infarction
- CVA/stroke
- Congestive heart failure (New York Heart Association [NYHA] Class III or IV
- Uncontrolled clinically significant arrhythmias.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Patients with previously treated brain metastases or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial...
- Has received a live vaccine within 30 days of the planned start of study drug. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza...
- Patients known to be positive for active Hepatitis B (HBsAg reactive with detectable HBV DNA), or Hepatitis C (HCV RNA (qualitative) is detected)
- Patients with chronic hepatitis B (positive HBsAg and/or HBcAb and negative HBV DNA by PCR) are eligible for this study if they are on suppressive anti-viral therapy and deemed safe by a gastroenterologist
- Patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution will be considered eligible.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) disease that is not controlled. Note HIV-positive patients will be considered eligible if:
- Established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment
- CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
- No opportunistic infection within the past 12 months
- Has a known history of active TB (Bacillus Tuberculosis)
- Women who are pregnant or breastfeeding
- Patients expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through three months after the last dose of study treatment(s).
- Female participants of childbearing potential and male participants who are unwilling to use acceptable method(s) of effective contraception during study treatment and until six months for female and three months for...
- The presence of a concurrent active malignancy that in the opinion of the investigator could compromise the conduct of the study or interfere with determining the outcomes of the study objectives.
- History of non-infectious colitis.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 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.