NCT04145622PHASE1, PHASE2RECRUITING

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)

Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC

No open prediction endpoints

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Key Facts

Study type

INTERVENTIONAL

Conditions

Advanced Solid Tumor, Malignant Solid Tumor

Interventions

Ifinatamab deruxtecan (I-DXd)

Enrollment

250 participants

Primary completion

Apr 2027

Study completion

Oct 2029

First posted

Oct 2019

Last updated

May 2026

Primary Endpoints (CT.gov)

Evaluate the incidence of dose-limiting toxicities (DLTs)

Time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part

Evaluate the incidence of adverse events (AEs)

Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)

Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Secondary Endpoints

Characterize the PK parameter AUClast

Characterize the PK parameter AUCtau

Characterize the PK parameter Cmax

Eligibility Criteria

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator * Has adequate cardiac, hematopoietic, renal and hepatic functions * Has an adequate treatment washout period prior to start of study treatment * Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometri…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov