Trial reportThe oncologist2026
Dose-expansion study of OBI-999, a Globo H-targeting antibody-drug conjugate, in patients with advanced solid tumors.
Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04084366 (A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors), which is not on this map. Not yet cited in PubMed.
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A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors
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14 authors.
Funding
Abstract
backgroundOBI-999 is an antibody-drug conjugate consisting of the Globo H-targeting antibody OBI-888 linked to the cytotoxic payload monomethyl auristatin E. In a dose-escalation study, the OBI-999 recommended phase 2 dose (RP2D) was 1.2 mg/kg every 3 weeks. This dose-expansion study evaluated the efficacy and safety of OBI-999 in patients with pancreatic cancer, colorectal cancer (CRC), or other tumor types ("basket cohort") and tumoral Globo H H-scores ≥100 (NCT04084366). PATIENTS AND
methodsPatients were treated at RP2D of OBI-999. We assessed response, progression-free survival (PFS), treatment-emergent adverse events (TEAEs), and pharmacokinetics of OBI-999.
resultsOf 29 patients treated, 23 were evaluable for response. Eight (34.8%) had stable disease): pancreatic cancer, 4 of 7; CRC, 2 of 8; basket cohort, 2 of 8. No objective response was noted. The median time on treatment was 22 days. No association between H-score and tumor size reduction was noted. Median PFS was 3.3 months, 1.3 months, and 1.4 months in the pancreatic, CRC, and basket cohorts, respectively. One patient (3.4%) experienced a serious TEAE related to OBI-999 (febrile neutropenia) that led to discontinuation of OBI-999; the TEAE resolved 3 days after onset. OBI‑999 showed consistent pharmacokinetics with comparable exposure at RP2D across cohorts.
conclusionsOBI-999 had a favorable safety profile. Although 34.8% of patients had disease stabilization, no objective response was noted, likely owing to inefficient antigen binding, suboptimal systemic exposure at the tolerated dose, and complex tumor biology.
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