Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Terminated

Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

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

NCT04084366↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlyHas not shown its expected therapeutic potential for the enrolled patients in this trial (Enrollment)
Phase
Phase 1 / Phase 2
Status
Terminated
Study type
Interventional
Start
25 November 2019
Expected end
27 October 2023
Enrollment
44 participants
Sites
4
Primary outcomes
Objective Response Rate (ORR) (CR+PR)
Sponsor
Industry
Results posted
2025-03-26
Last update
26 March 2025

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) (CR+PR) [Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first]. Number, % of participants (95% Confidence Interval). Part A, Dose Escalation - OBI-999 0.4 mg/kg (n=3): 0 (0 to 70.8); Part A, Dose Escalation - OBI-999 0.8 mg/kg (n=3): 0 (0 to 70.8); Part A, Dose Escalation - OBI-999 1.2 mg/kg (n=6): 0 (0 to 45.9); Part A, Dose Escalation - OBI-999 1.6 mg/kg (n=3): 0 (0 to 70.8); Part B, Cohort Expansion - Cohort 1, Pancreatic (n=7): 0 (0 to 41); Part B, Cohort Expansion - Cohort 2, Colorectal Cancer (n=8): 0 (0 to 36.9); Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2) (n=8): 0 (0 to 36.9).

Papers 2