IDeate-PanTumor02: A phase 1b/2 study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients (pts) with recurrent or metastatic solid tumors.
Background: B7-H3 is highly expressed in many solid tumors but has limited expression in normal tissues; high B7-H3 expression is associated with shorter overall survival (OS) in several tumor types. I-DXd is a B7-H3–directed antibody–drug conjugate (anti−B7-H3 mAb covalently linked to a topoisomerase I inhibitor cytotoxic payload [DXd] via an enzymatically cleavable peptide-based linker). It showed promising efficacy in pts with advanced solid tumors in the Phase 1/2 IDeate-PanTumor01 study, with objective responses in 6 of the 7 tumor types with ≥5 pts (small cell lung cancer [SCLC], esophageal squamous cell carcinoma, metastatic castration-resistant prostate cancer, squamous non-small cell lung cancer, head and neck squamous cell carcinoma [HNSCC], and endometrial cancer). I-DXd also showed encouraging antitumor activity in 88 pretreated pts with extensive-stage SCLC in the Phase 2 IDeate-Lung01 study, with greater efficacy at the 12-mg/kg than the 8-mg/kg dose (objective response rates [ORRs] of 54.8% [95% CI, 38.7–70.2] and 26.1% [95% CI, 14.3–41.1], respectively). I-DXd has demonstrated a manageable and tolerable safety profile across tumor types. We describe a study investigating the efficacy and safety of I-DXd in pts with advanced solid tumors with substantial unmet medical needs. Methods: IDeate-PanTumor02 (NCT06330064) is a global, multicenter, open-label, single-arm, parallel-cohort, Phase 1b/2 study in ~520 adults with recurrent or metastatic solid tumors (endometrial cancer; HNSCC; pancreatic ductal adenocarcinoma; colorectal cancer; hepatocellular carcinoma [HCC]; esophageal/gastroesophageal/gastric adenocarcinoma; urothelial carcinoma; ovarian cancer; cervical cancer; biliary tract cancer; HER2-low breast cancer [BC]; HER2-negative BC; and cutaneous melanoma). Eligible pts will have received ≥1 systemic therapy for the selected tumor type and have an ECOG PS of ≤1. The study will be divided into 2 parts: Stage 1 and Stage 2 (n≈20 per stage per cohort). Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. All cohorts except the HCC cohort will receive I-DXd 12 mg/kg every 3 weeks (Q3W). The HCC cohort includes a safety run-in part to assess tolerability and the potential need for dose adjustment; the planned starting dose is 8 mg/kg Q3W, which may be escalated. Primary endpoints are ORR per investigator (all cohorts) and safety (HCC safety run-in only). Secondary endpoints are safety, duration of response, progression-free survival, OS, disease control rate, pharmacokinetics, and immunogenicity. The Kaplan–Meier method will be used to estimate time-to-event endpoints, the Brookmeyer and Crowley method for median event times, and the Clopper–Pearson exact method to summarize descriptively endpoints with proportion. Enrollment is ongoing.
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Author Details
Takahiro Kogawa
Department of Advanced Medical Development, The Cancer Institute Hospital of JFCR, Tokyo, Japan
Abstract Details
Meeting
2025 ASCO Annual Meeting
Session Type
Poster Session
Session Title
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Track
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
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