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Spots Global Cancer Trial Database for A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

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Trial Identification

Brief Title: A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Official Title: P1b, Open-Label, Safety, Tolerability, Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w/ a CD40 Agonist (CDX-1140) in Patients w/ Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo

Study ID: NCT05484011

Interventions

odetiglucan
CDX-1140

Study Description

Brief Summary: The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 32 weeks of chemotherapy. Up to 45 patients will be enrolled and dosed (30 patients in Part A and 15 in Part B).

Detailed Description: This is a multiple institution, open-label, 2-part Phase 1b study to determine the MTD (and/ or RP2D), safety, tolerability, and preliminary efficacy of the combination of odetiglucan and CDX-1140 for the treatment of patients with metastatic PDAC with evidence of response or stable disease during a minimum of 16 and no more than 32 weeks of therapy immediately prior to study enrollment. Part A will identify the MTD and/ or RP2D in two cohorts of patients enrolled per ABA status (Cohort 1=ABA+ and Cohort 2=ABA-) and Part B will assess an alternative dosing regimen of RP2D in an anti-beta glucan antibody ABA+, ABA- or ABA mixed population (ABA+ and ABA-) based on observations in Part A. Product: Odetiglucan and CDX-1140 5 Protocol/Amendment No.: PGG-PAN2111, Amd.0010 Confidential - HiberCell Inc. In Part A, a 3 + 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan (the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose (RP2D) based on prior Phase 1 clinical assessment). Two cohorts of patients will be enrolled (ABA+ and ABA-) and proceed independently through the 3+3 de-escalation assessment; up to 30 patients will be enrolled. The following 2 treatment cohorts will be evaluated for safety, tolerability, and preliminary efficacy: * ABA+: Patients with ABA value ≥20 mcg/mL ABA * ABA-: Patients with ABA value \<20 mcg/mL ABA Both cohorts will initiate at Dose Level 1 and de-escalate to Dose Level -1 based on the respective 21-day DLT period: * Dose Level 1: Odetiglucan 4 mg/kg IV plus CDX-1140 1.5 mg/kg * Dose Level -1: Odetiglucan 4 mg/kg IV plus CDX-1140 0.72 mg/kg Treatment will be administered in 3-week cycles. Odetiglucan will be administered weekly on Days 1, 8, and 15 of each cycle followed \~15-30 minutes later by administration of CDX-1140 1.5 mg/kg or 0.72 mg/kg IV Day 1 of each cycle. Part B, if opened, will enroll up to 15 patients to receive odetiglucan 4 mg/kg plus the CDX-1140 RP2D identified in Part A. As in Part A, treatment will be administered in 3-week cycles, however, both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle (no odetiglucan administration on Days 8 and 15 as in Part A). If the RP2D differs between Cohort 1 and Cohort 2 at the end of Part A, the Sponsor in consult with the SMC, may select a single RP2D to investigate or investigate both RP2Ds. If a larger total enrollment is required, the protocol will be amended to support.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HonorHealth Research Institute, Scottsdale, Arizona, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

Contact Details

Name: Mark O'Hara

Affiliation: University of Pennsylvania

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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