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A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
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.
Study details:
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors previously treated with 1 or more systemic therapies for the selected tumor indication. The study will be divided into 2 parts: Stage 1 and Stage 2. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed.
The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd and will assess the maximum tolerated dose (MTD). Once the MTD is established, participants with HCC will be further treated with this dose of I-DXd.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-10
Primary completion: 2028-07-25
Study completion finish: 2028-07-25
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06330064
Intervention or treatment
DRUG: Ifinatamab deruxtecan
Conditions
- • Recurrent or Metastatic Solid Tumors
Find a site
Closest Location:
St John of God Subiaco Hospital
Research sites nearby
Select from list below to view details:
St John of God Subiaco Hospital
Subiaco, Not Specified, Australia
Princess Alexandra Hospital
Woolloongabba, Not Specified, Australia
St Vincent'S Hospital Sydney
Darlinghurst, Not Specified, Australia
Genesiscare North Shore (Oncology)
St Leonards, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort 1: Endometrial Cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 2: Head and Neck Squamous Cell Carcinoma
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 3: Pancreatic Ductal Adenocarcinoma
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 4: Colorectal Cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 5: Hepatocellular Carcinoma
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 7: Urothelial carcinoma
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 8: Ovarian cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 9: Cervical cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 10: Biliary tract cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancer
| DRUG: Ifinatamab deruxtecan
|
EXPERIMENTAL: Cohort 13: Cutaneous melanoma
| DRUG: Ifinatamab deruxtecan
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Objective Response Rate (ORR) as Assessed by Investigator | ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first up to approximately 57 months |
Number of Participants Reporting Dose-limiting Toxicities in the HCC Cohort | A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT evaluation period (from C1D1 to the end of Cycle 1 in Safety Run-in) and is Grade 3 or above, according to NCI-CTCAE version 5.0, with the exceptions as noted in the protocol. | Cycle 1 Day 1 to Cycle 1 Day 21 |
Number of Participants Reporting Treatment-emergent Adverse Events and Death in the HCC Cohort | A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. AEs will be coded using MedDRA and will be graded using NCI-CTCAE v5.0. | From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. AEs will be coded using MedDRA and will be graded using NCI-CTCAE v5.0. | From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months |
Duration of Response (DoR) | DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target and non-target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | From the time of the first dose of study drug until the date of documented disease progression (confirmed by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months |
Progression-free Survival (PFS) | PFS is defined as the time from the start of study treatment to the earlier of the dates of the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by the Investigator. | From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months |
Disease Control Rate (DCR) | DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target and non-target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. | From the time of the first dose of study drug until the date of documented disease progression (by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months |
Overall Survival (OS) | OS is defined as the time interval from the date of the first dose of study drug to the date of death from any cause. | From the date of the first dose of drug up to the date of death due to any cause, up to approximately 57 months |
Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd | Plasma pharmacokinetic parameters will be estimated using noncompartmental methods. | Cycles 1 and 3 Day 1: predose, end of infusion, 3 hours (hr), 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: predose and end of infusion; Cycle 7 and every 2 cycles thereafter up to EOS (57 months) predose (every cycle is 21 days) |
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd | Plasma pharmacokinetic parameters will be estimated using noncompartmental methods. | Cycles 1 and 3 Day 1: predose, end of infusion, 3 hours (hr), 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: predose and end of infusion; Cycle 7 and every 2 cycles thereafter up to EOS (57 months) predose (every cycle is 21 days) |
Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd | Plasma pharmacokinetic parameters will be estimated using noncompartmental methods. | Cycles 1 and 3 Day 1: predose, end of infusion, 3 hours (hr), 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: predose and end of infusion; Cycle 7 and every 2 cycles thereafter up to EOS (57 months) predose (every cycle is 21 days) |
Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd | Plasma pharmacokinetic parameters will be estimated using noncompartmental methods. | Cycles 1 and 3 Day 1: predose, end of infusion, 3 hours (hr), 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: predose and end of infusion; Cycle 7 and every 2 cycles thereafter up to EOS (57 months) predose (every cycle is 21 days) |
Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd | Plasma pharmacokinetic parameters will be estimated using noncompartmental methods. | Cycles 1 and 3 Day 1: predose, end of infusion, 3 hours (hr), 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: predose and end of infusion; Cycle 7 and every 2 cycles thereafter up to EOS (57 months) predose (every cycle is 21 days) |
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) | Anti-drug antibodies will be measured in the plasma using a validated assay. | Baseline up to 57 months |
Percentage of Participants Who Have Treatment-emergent ADA | Anti-drug antibodies will be measured in the plasma using a validated assay. | Baseline up to 57 months |
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