Recurrent or Metastatic Solid Tumors study: Ifinatamab deruxtecan
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?
This is an investigational medicine being studied as a potential treatment for various types of recurrent or metastatic solid tumors. It is designed to attach to specific targets on cancer cells and deliver a chemotherapy drug directly into them.
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 aims to find out if the drug works to treat cancer and to check for any side effects.
- Who it's for
- The study is looking for adults with certain types of cancer that have come back or spread to other parts of the body.
- What's involved
- Participants will receive the study drug and undergo regular medical tests and check-ups to monitor their health and the cancer.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- 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 consent to provide a pretreatment tumor sample which has not been previously irradiated.
- 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.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Additional for EC Participants
You likely can't join if
- 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 (e.g., T-DXd) due to treatment-related toxicities.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring...
- Inadequate treatment washout period before enrollment as specified in the protocol.
- Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.
See the full eligibility criteria
Who can join
- Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated.
- 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.
- 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).
- 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.
- Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a greater than (\>)90-degree abutment or encasement of a major blood vessel.
- Participants with no prior history of Grade greater than or equal to (≥)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...
- 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 metastatic CRC with microsatellite stable status (MSS).
- 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, or relapse or progression after 2 lines of therapy if the participant has...
- 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. a.
- 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.
- Participants 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.
- Participants should receive prior anti-programmed death 1 (PD-1)//programmed death-ligand 1 (PD-L1) treatment and/or tisotumab vedotin if those are standard of care in the country, unless the participant is ineligible...
- 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.
- Participants 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. Participants with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2...
- 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.
- Disease that is relapsed/refractory to standard systemic therapy OR
- Disease for which standard therapy does not exist OR
- Disease for which standard therapy is not considered appropriate by the investigator.
- Participants with mixed histology of large-cell neuroendocrine carcinoma (LCNEC) and SCLC are eligible if the neuroendocrine component predominates and represents at least 50% of the overall tumor tissue.
What rules you out
- 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 (e.g., 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.
- Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.
The study team makes the final eligibility decision.
Where it is enrolling
- 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
- White Plains, 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
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
- Caba, Ciudad Autonoma Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
+ 64 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, but 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?
This study is enrolling now at 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 78 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.