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Tests treatment safety and results for Recurrent or Metastatic Solid Tumors
Official title A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
ClinicalTrials.gov ID: NCT06330064
What this study is testing
What is Ifinatamab deruxtecan?
Ifinatamab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent or metastatic solid tumors.
Also referred to as I-DXd.
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 is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.
- 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
- Participants must meet all of the following criteria to be included in the study: Common for All Participants
- Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue...
- Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years).
- At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid...
- Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting.
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be included in the study: Common for All Participants
- Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of...
- Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years).
- At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.
- Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Additional for EC Participants
- Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.
- Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). people with actionable target tumor mutation should have been...
- Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and...
- Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. people with actionable target tumor mutation should have been previously treated with targeted therapy...
- Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a \>90-degree abutment or encasement of a major blood vessel.
- Participants with no prior history of Grade ≥3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the...
- Documented p16 status for oropharyngeal cancer (historical results are acceptable if available). Additional Inclusion Criterion for PDAC Participants 1\. Pathologically or cytologically documented unresectable or...
- Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status.
- Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal...
- No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan. Additional for HCC Participants
- Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American...
- Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced/metastatic setting, with a maximum of 2 prior lines. people with actionable target tumor...
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
- Liver function status should be Child-Pugh (CP) Class A.
- Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.
- Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment. Additional for Ad-eso/GEJ/Gastric Participants
- Pathologically or cytologically documented unresectable or metastatic Ad-eso/GEJ/Gastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced/metastatic setting. people with...
- If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization [ISH] positive, as classified by American Society of Clinical Oncology - College of American Pathologists...
- Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant...
- Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3...
- At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.
- Perioperative systemic therapies will be counted as 1 line of therapy.
- To meet requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.
- people with actionable target tumor mutation should have been previously treated with targeted therapy.
- The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy. Additional for CC Participants
- Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. people with actionable target tumor mutation...
- Participants should receive prior anti-programmed death 1/programmed death-ligand 1 treatment and/or tisotumab vedotin if those are standard of care in the country, unless the subject is ineligible for these treatments...
- Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab...
- Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.
- Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.
- people with actionable target tumor mutation should have been previously treated with targeted therapy. Additional for BTC Participants
- Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).
- Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.
- Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and/or mucinous cystic neoplasms (Please note that the histological subtypes listed...
- Pathologically or cytologically documented unresectable or metastatic BC.
- Low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.
- Progression on or after treatment with trastuzumab deruxtecan (T-DXd).
- Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. people with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a...
- Pathologically or cytologically documented unresectable or metastatic BC.
- Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.
- Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3...
- Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.
- Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks...
- Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, T-DXd) due to treatment-related toxicities.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Inadequate treatment washout period before enrollment as specified in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Whittier, California, United States
- Skokie, Illinois, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Westbury, New York, United States
- Chattanooga, Tennessee, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Amarillo, Texas, United States
- Dallas, Texas, United States
- Pearland, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Wenatchee, Washington, United States
- Buenos Aires, Argentina
- Caba, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Mar del Plata, Argentina
- St Leonards, New South Wales, Australia
+ 73 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 Los Angeles, California, United States; Whittier, California, United States; Skokie, Illinois, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Westbury, New York, United States and 87 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.