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Switch Maintenance in Pancreatic | Clinical Trials | Clareo Health

SUSPENDEDPHASE1/PHASE2

Switch Maintenance in Pancreatic

Phase Ib Open-Label, Multicenter, Study Evaluating the Safety and Efficacy of 'Switch Maintenance' Combination Immunotherapy Using AB154, AB122, and Sotigalimab in Patients With Metastatic Pancreatic Cancer

NCT05419479•James Cleary, MD, PhD

View on ClinicalTrials.gov

Summary

This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body. This research study involves immunotherapy. Immunotherapy triggers the body's immune system to fight cancer cells. The names of the study drugs involved in this study are: * Domvanalimab (also known as AB154) * Zimberelimab (also known as AB122) * APX005M

Detailed Description

This is an open-label, Phase 1b/2, multicenter, randomized study evaluating the safety and efficacy of 'switch maintenance' combination immunotherapy (domvanalimab) zimberelimab and APX005M versus 'continuous maintenance' in patients with metastatic pancreatic cancer following 4-6 months of FOLFIRINOX The names of the study drugs involved in this study are: * Domvanalimab (also known as AB154) * Zimberelimab (also known as AB122) * APX005M The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized into one of two groups: * Arm A will receive domvanalimab, zimberelimab, and APX005M every two weeks through an infusion. * Arm B will receive leucovorin, fluorouracil, and irinotecan every two weeks through an infusion If you are in Arm B and the drugs stop working, participants may receive the drugs given in Arm A. Participants will receive study treatment as long the disease does not worsen or there are no serious side effects for a maximum of 26 cycles (2 years) and will be followed for 12 months after the discontinue the study drugs. It is expected that about 46 people will take part in this research study. This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug or drugs and also tries to define the appropriate dose of the investigational drug(s) to use for further studies. Phase II clinical trials test the safety and effectiveness of an investigational drug or drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved domvanalimab, zimberelimab, or APX005M as a treatment for any disease. drug regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* Have no evidence of progression by neurologic symptoms or sign for at least 4 weeks prior to the first dose.
•* Metastatic brain lesions do not require immediate intervention.
•* Carcinomatous meningitis is excluded regardless of clinical stability.
•Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
•Participants must be willing to undergo a pre-treatment fresh tumor biopsy.
•Participants must be willing to undergo an on-treatment tumor biopsy (if medically feasible).
•Participants must have archival tissue available for analysis, which will be used for correlative studies if a pretreatment biopsy reveals necrotic tissue.
•* The effects of domvanalimab, zimberelimab, and APX005M on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (See Section 5.6) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of domvanalimab, zimberelimab, or APX005M administration.
•* Women of childbearing potential (WOCBP), defined as not surgically sterilized and between menarche and 1-year post menopause, must have a negative serum pregnancy test within 7 days prior to the first dose of investigational therapies and a negative urine (or serum) pregnancy test within 3 days prior to the first dose of investigational therapies.
•* WOCBP must agree to use highly effective methods of contraception from the time of consent, through the duration of study treatment, and 5 months after the last dose of investigational therapies.
+24 more criteria

Exclusion Criteria

•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
•Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX with stable disease or better.
•Age ≥18 years. Because no dosing or adverse event data are currently available on the use of domvanalimab + zimberelimab + APX005M in participants \<18 years of age, children are excluded from this study.
•ECOG performance status ≤1
•Participants must have adequate organ and marrow function as defined below:
•* leukocytes ≥3,000/mcL
•* absolute neutrophil count ≥1,500/mcL
•* platelets ≥100,000/mcL
•* total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN
•* AST(SGOT)/ALT(SGPT) ≤ 2.5 x institution's upper limit of normal (ULN) for patients with no concurrent liver metastases, OR ≤ 5.0 x institution's ULN for patients with concurrent liver metastases creatinine OR glomerular filtration rate (GFR) creatinine ≤ 2 x ULN OR GFR measured by calculated creatinine clearance (CrCl) \> 45 mL/min. CrCl can be calculated using the Cockroft-Gault method.
+8 more criteria

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

November 30, 2022

Primary Completion Date

January 31, 2027

Completion Date

September 30, 2028

Last Updated

February 24, 2026

Enrollment

ESTIMATED participants

Conditions

Pancreatic CancerAdenocarcinoma of the PancreasSquamous Cell Carcinoma of PancreasAdenosquamous Carcinoma of the Pancreas

Interventions

ZIMBERELIMAB

DRUG

DOMVANALIMAB

DRUG

APX005M

DRUG

FOLFIRI

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Switch Maintenance in Pancreatic

Inclusion Criteria

Exclusion Criteria

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Resilience and Equity in Aging, Cancer, and Health (REACH)

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients