Odetiglucan + CD40 Agonist for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: HiberCell, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults with metastatic pancreatic cancer who've had a positive response or stable disease after 16-32 weeks of chemotherapy. They must have specific blood antibody levels, be in good physical condition (ECOG 0 or 1), and have normal organ function tests. Women must not be pregnant and agree to use contraception.

Inclusion Criteria

My kidney function tests are within the required range.

I've had 16-32 weeks of first-line chemotherapy with no cancer progression.

My blood clotting time is normal or managed with medication.

See 18 more

Exclusion Criteria

I have never been treated with CD40 antibodies or similar immune-based treatments for cancer.

I do not have a known or suspected spinal cord or brain lining disease.

I have a history of HIV, hepatitis B, or hepatitis C.

See 21 more

Treatment Details

Interventions

CDX-1140 (Other)
odetiglucan (Other)

Trial OverviewThe study aims to find the safest dose for odetiglucan combined with CDX-1140, assessing its safety and tolerability. Up to 45 patients will participate, looking at how their bodies handle the drugs and any potential toxic effects at different doses.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment2 Interventions

Patients will have regularly scheduled study visits on day 1 of each cycle. On Day 1 patients will receive odetiglucan and CDA-1140. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year.

Group II: Part AExperimental Treatment2 Interventions

Patients will have regularly scheduled study visits on days 1, 8, and 15 of each cycle. On Day 1 patients will receive odetiglucan and CDX-1140. On Days 8 \& 15 only odetiglucan. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year.