Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

NCT04195347 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CRSPANCI-2019-08205
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the severity of pancreatitis will be estimated. Primary Objectives To assess the safety of CM4620 administration in children and young adults with asparaginase associated pancreatitis (AAP). To profile dose-limiting toxicities and responses of the patients treated in the dose-finding phase. To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in children with AAP. Secondary Objectives To determine the effect of CM4620 on the incidence of severe pancreatitis To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome (SIRS).

Conditions

Acute Pancreatitis

Keywords

Acute Pancreatitis; Asparaginase; Asparaginase Associated Pancreatitis; Acute Lymphoblastic Leukemia; Acute Lymphoblastic Lymphoma; CM4620; Children; SIRS; Systemic Inflammatory Response; Young Adults

Outcome Measures

Primary Outcomes (2)

• The number of CTCAE grade 3-5 events

  Drug safety measuring the number of CTCAE grade 3-5 events

  Within 28 days of receiving the medication

• Responses to CM4620

  We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging

  28-35 days after study entry.

Secondary Outcomes (4)

• Effect of CM4620 measured by levels of pancreatic enzymes

  72 hours after study entry

• Effect of CM4620: Necrosis

  28-35 days from study entry

• Effect of CM4620: Pseudocyst

  28-35 days from study entry

• Effect of CM4620: Incidence of SIRS

  48-72 hours after study entry

Study Arms (1)

CM4620 Treatment

EXPERIMENTAL

Phase I: Cohort 1 patients receive CM4620 IV at dose level 1 on days 1-4. Cohort 2 patients receive CM4620 IV at dose level 2 on days 1-4. Cohort 3 patients receive CM4620 IV at either dose level 1 or 2 on days 1-4 Phase II: Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I.

Drug: CM4620

Interventions

CM4620 DRUG

IV

Also known as: CM4620-IE

CM4620 Treatment

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis.
• Receipt of any form of asparaginase within the prior 49 days.
• Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.

You may not qualify if:

• Prior episode of pancreatitis.
• QTc at baseline \> 450 msec.
• Creatinine \> 3x the upper limit of normal for age or total bilirubin \>3x the upper limit for normal for age without evidence of leukemic infiltrate or hemolysis.
• Receipt of another investigational agent within the prior 7 days.
• History of allergy to eggs or known hypersensitivity to any component of CM4620.
• Positive pregnancy test or breastfeeding. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Males and females of childbearing potential must agree to use effective contraception for at least twelve months following the completion of therapy.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• CalciMedica, Inc.: collaborator

Study Sites (2)

Novant Health Presbyterian Hemby Children's Hospital

Charlotte, North Carolina, 28204, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

MeSH Terms

Conditions

Pancreatitis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

zegocractin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Seth E. Karol, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seth E. Karol, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 11, 2019
• Study Start: September 4, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US (2)