Health TrialsbyHealthPanel

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

ConditionRecurrent or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 consent and after progression during/after treatment with the participant's most recent cancer therapy regimen is also acceptable.

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ifinatamab deruxtecan

    Drug

    Intravenous administration

Treatment groups

520 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: Cohort 1: Endometrial CancerExperimental treatment 1 intervention
Group B: Cohort 2: Head and Neck Squamous Cell CarcinomaExperimental treatment 1 intervention
Group C: Cohort 3: Pancreatic Ductal AdenocarcinomaExperimental treatment 1 intervention
Group D: Cohort 4: Colorectal CancerExperimental treatment 1 intervention
Group E: Cohort 5: Hepatocellular CarcinomaExperimental treatment 1 intervention
Group F: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomachExperimental treatment 1 intervention
Group G: Cohort 7: Urothelial carcinomaExperimental treatment 1 intervention
Group H: Cohort 8: Ovarian cancerExperimental treatment 1 intervention
Group I: Cohort 9: Cervical cancerExperimental treatment 1 intervention
Group J: Cohort 10: Biliary tract cancerExperimental treatment 1 intervention
Group K: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancerExperimental treatment 1 intervention
Group L: Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancerExperimental treatment 1 intervention
Group M: Cohort 13: Cutaneous melanomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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.

Time frame
Cycle 1 Day 1 to Cycle 1 Day 21
3

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.

Time frame
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 outcomes

1

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.

Time frame
From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months
2

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.

Time frame
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
3

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.

Time frame
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
4

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.

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
Apply now