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Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers

Primary Purpose

Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IGM-8444
FOLFIRI
Bevacizumab (and approved biosimilars)
Birinapant
Venetoclax
Gemcitabine
Docetaxel
Azacitidine
Sponsored by
IGM Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Hematological cancer, Newly diagnosed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Age ≥ 18 years at time of signing ICF
  • ECOG Performance Status of 0 or 1
  • Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
  • Adequate hepatic and renal function and adequate bone marrow reserve function
  • For combination cohorts, patients must be eligible to receive the chemotherapy or targeted agent.
  • Ph1a only: No more than three prior therapeutic regimens
  • Ph1b only: FOLFIRI naive subjects that received no more than 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting

Key Exclusion Criteria:

  • Inability to comply with study and follow-up procedures.
  • Prior DR5 agonist therapy.
  • Concomitant use of agents well-known to cause liver toxicity.
  • Concomitant use of anti-cancer agents
  • Palliative radiation to bone metastases within 2 weeks prior to Day 1.
  • Major surgical procedure within 4 weeks prior to Day 1.
  • Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible.
  • Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment
  • Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment.
  • Ph1b: Subjects who have previously received FOLFIRI treatment for advanced or metastatic disease

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • USC NorrisRecruiting
  • UC Irvine Manchester PavilionRecruiting
  • UCSFRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • SCRI at HealthoneRecruiting
  • Yale Cancer CenterRecruiting
  • FL Cancer Specialists - Lake MaryRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Norton Cancer InstituteRecruiting
  • Maryland Oncology Hematology, PA - ColumbiaRecruiting
  • START MidwestRecruiting
  • Minnesota Oncology - Minneapolis ClinicRecruiting
  • Washington University School of MedicineRecruiting
  • Gabrail Cancer ResearchRecruiting
  • Stephenson Cancer CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • SCRI - TennesseeRecruiting
  • Texas Oncology - AustinRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • The University of Texas, MD AndersonRecruiting
  • Texas Oncology - San Antonio NortheastRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • Seattle Cancer Alliance - Fred HutchRecruiting
  • Southern Medical Day Care CentreRecruiting
  • Tasman HealthRecruiting
  • Samsung Medical CenterRecruiting
  • Gachon University Gil HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Ph1a: IGM-8444 Single Agent Alternate Dosing Escalation

Ph1a: IGM-8444 + FOLFIRI ± bevacizumab Escalation and Expansion

Ph1a: IGM-8444 + Birinapant Escalation and Expansion

Ph1a: IGM-8444 + Venetoclax Escalation and Expansion

Ph1a: IGM-8444 + Docetaxel + Gemcitabine Escalation and Expansion

Ph1a: IGM-8444 + Venetoclax + Azacitidine Escalation and Expansion

Ph1b: IGM-8444 + FOLFIRI ± Bevacizumab

Ph1b: FOLFIRI ± Bevacizumab

Arm Description

IGM-8444 will be administered intravenously as a single agent on an alternate dosing schedule.

IGM-8444 will be administered intravenously in combination with FOLFIRI.

IGM-8444 will be administered intravenously in combination with Birinapant which will also be administered intravenously.

IGM-8444 will be administered intravenously in combination with Venetoclax.

IGM-8444 will be administered intravenously in combination with Docetaxel and Gemcitabine.

IGM-8444 will be administered intravenously in combination with Venetoclax and Azacitidine.

IGM-8444 will be administered intravenously in combination with FOLFIRI ± bevacizumab

Standard of Care FOLFIRI ± bevacizumab will be administered intravenously

Outcomes

Primary Outcome Measures

Ph1a: Adverse Events of IGM-8444 as single agent and with FOLFIRI ± bevacizumab, IGM-8444 with birinapant, IGM-8444 with venetoclax, IGM-8444 with venetoclax and azacitadine, and IGM-8444 with gemcitabine and docetaxel
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
Ph1a: To identify the recommended expansion dose for IGM-8444 as single agent, with FOLFIRI ± bevacizumab, IGM-8444 with birinapant, IGM-8444 with venetoclax, IGM-8444 with venetoclax and azacitadine, and IGM-8444 with gemcitabine and docetaxel
Relationship between IGM-8444 dose and safety, PK, activity, and endpoints.
Ph1b: Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigators

Secondary Outcome Measures

Ph1a: Area Under the Curve (AUC) of IGM-8444
Area Under the Curve (AUC) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Ph1a: Clearance (CL) of IGM-8444
Clearance (CL) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Ph1a: Volume of distribution (V) of IGM-8444
Volume of distribution (V) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Ph1a: Immunogenicity
Immunogenicity as assessed by detection of anti-drug antibodies (ADAs) to IGM-8444
Ph1a: Objective Response Rate (ORR)
Preliminary efficacy of objective response rate (ORR)
Ph1a and Ph1b: Duration of Response (DoR)
Preliminary efficacy of duration of response (DoR)
Ph1a and Ph1b: Progression-Free Survival (PFS)
PFS is defined as the time from first dose (Ph1a) or randomization (Ph1b) to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Ph1a and Ph1b: Overall Survival (OS)
OS is defined as the time from first dose (Ph1a) or randomization (Ph1b) to death due to any cause
Ph1b: Adverse events of IGM-8444 + FOLFIRI ± bevacizumab
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0

Full Information

First Posted
September 4, 2020
Last Updated
October 23, 2023
Sponsor
IGM Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04553692
Brief Title
Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers
Official Title
An Open-label, Multicenter, Phase 1a/1b Study of IGM-8444 as a Single Agent and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IGM Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab).
Detailed Description
Patients will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. IGM-8444 will be used as a single agent and in combination with numerous other agents where standard therapeutic regimens do not exist, have proven to be ineffective or intolerable, or are considered inappropriate. Colorectal patients may be enrolled in Phase 1b, an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab) IGM-8444 will be investigated in numerous tumor types including all-comers solid tumors, colorectal carcinoma (CRC), sarcoma, non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML), and chronic lymphocytic leukemia (CLL). IGM-8444 will be administered intravenously (IV). An alternative dosing schedule may be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia
Keywords
Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Hematological cancer, Newly diagnosed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
Phase 1a is non-randomized; Ph1b is randomized
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ph1a: IGM-8444 Single Agent Alternate Dosing Escalation
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously as a single agent on an alternate dosing schedule.
Arm Title
Ph1a: IGM-8444 + FOLFIRI ± bevacizumab Escalation and Expansion
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with FOLFIRI.
Arm Title
Ph1a: IGM-8444 + Birinapant Escalation and Expansion
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with Birinapant which will also be administered intravenously.
Arm Title
Ph1a: IGM-8444 + Venetoclax Escalation and Expansion
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with Venetoclax.
Arm Title
Ph1a: IGM-8444 + Docetaxel + Gemcitabine Escalation and Expansion
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with Docetaxel and Gemcitabine.
Arm Title
Ph1a: IGM-8444 + Venetoclax + Azacitidine Escalation and Expansion
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with Venetoclax and Azacitidine.
Arm Title
Ph1b: IGM-8444 + FOLFIRI ± Bevacizumab
Arm Type
Experimental
Arm Description
IGM-8444 will be administered intravenously in combination with FOLFIRI ± bevacizumab
Arm Title
Ph1b: FOLFIRI ± Bevacizumab
Arm Type
Experimental
Arm Description
Standard of Care FOLFIRI ± bevacizumab will be administered intravenously
Intervention Type
Drug
Intervention Name(s)
IGM-8444
Intervention Description
DR5 Agonist Investigational Drug
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Other Intervention Name(s)
Fluorouracil or 5-FU, Leucovorin, Irinotecan
Intervention Description
Chemotherapy Regimen
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (and approved biosimilars)
Other Intervention Name(s)
Avastin
Intervention Description
Targeted Therapy
Intervention Type
Drug
Intervention Name(s)
Birinapant
Intervention Description
SMAC-mimetic Investigational Drug
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta
Intervention Description
Targeted Therapy
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere, Docefrez
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
VIDAZA
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Ph1a: Adverse Events of IGM-8444 as single agent and with FOLFIRI ± bevacizumab, IGM-8444 with birinapant, IGM-8444 with venetoclax, IGM-8444 with venetoclax and azacitadine, and IGM-8444 with gemcitabine and docetaxel
Description
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
From Cycle 1 Day 1 through 28 days after the final dose of study drug
Title
Ph1a: To identify the recommended expansion dose for IGM-8444 as single agent, with FOLFIRI ± bevacizumab, IGM-8444 with birinapant, IGM-8444 with venetoclax, IGM-8444 with venetoclax and azacitadine, and IGM-8444 with gemcitabine and docetaxel
Description
Relationship between IGM-8444 dose and safety, PK, activity, and endpoints.
Time Frame
4 weeks
Title
Ph1b: Objective Response Rate (ORR)
Description
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigators
Time Frame
Study duration of approximately 36 months
Secondary Outcome Measure Information:
Title
Ph1a: Area Under the Curve (AUC) of IGM-8444
Description
Area Under the Curve (AUC) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Time Frame
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Title
Ph1a: Clearance (CL) of IGM-8444
Description
Clearance (CL) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Time Frame
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Title
Ph1a: Volume of distribution (V) of IGM-8444
Description
Volume of distribution (V) of IGM-8444 as a single agent and in combination with the anticancer agents listed above.
Time Frame
At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Title
Ph1a: Immunogenicity
Description
Immunogenicity as assessed by detection of anti-drug antibodies (ADAs) to IGM-8444
Time Frame
through end of treatment at approximately 6 months
Title
Ph1a: Objective Response Rate (ORR)
Description
Preliminary efficacy of objective response rate (ORR)
Time Frame
Study duration of approximately 36 months
Title
Ph1a and Ph1b: Duration of Response (DoR)
Description
Preliminary efficacy of duration of response (DoR)
Time Frame
Study duration of approximately 36 months
Title
Ph1a and Ph1b: Progression-Free Survival (PFS)
Description
PFS is defined as the time from first dose (Ph1a) or randomization (Ph1b) to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Time Frame
Study duration of approximately 36 months
Title
Ph1a and Ph1b: Overall Survival (OS)
Description
OS is defined as the time from first dose (Ph1a) or randomization (Ph1b) to death due to any cause
Time Frame
Study duration of approximately 36 months
Title
Ph1b: Adverse events of IGM-8444 + FOLFIRI ± bevacizumab
Description
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
From Cycle 1 Day 1 through 28 days after the final dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age ≥ 18 years at time of signing ICF ECOG Performance Status of 0 or 1 Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts. Adequate hepatic and renal function and adequate bone marrow reserve function. For combination cohorts, patients must be eligible to receive the chemotherapy or targeted agent. Ph1a only: No more than three prior therapeutic regimens. Ph1b only: Must be FOLFIRI naive subjects and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting. Key Exclusion Criteria: Inability to comply with study and follow-up procedures. Prior DR5 agonist therapy. Concomitant use of agents well-known to cause liver toxicity. Concomitant use of anti-cancer agents Palliative radiation to bone metastases within 2 weeks prior to Day 1. Major surgical procedure within 4 weeks prior to Day 1. Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible. Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment. Ph1b: Subjects who have previously received FOLFIRI treatment for advanced or metastatic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials
Phone
(877) 544-6728
Email
clinicaltrials@igmbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Humke, MD, PhD
Organizational Affiliation
IGM Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Email
clinicaltrials@igmbio.com
Facility Name
USC Norris
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlean Ketchens
Phone
323-865-3000
Email
Ketchens_C@med.usc.edu
Facility Name
UC Irvine Manchester Pavilion
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCI Chao Family Comprehensive Cancer Center
Phone
877-827-8839
Email
ucstudy@uci.edu
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phu Lam
Phone
415-353-8337
Email
Phu.Lam@ucsf.edu
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Beland
Phone
303-385-2000
Email
kelly.beland@usoncology.com
Facility Name
SCRI at Healthone
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Phone
720-754-2610
Email
CANN.DDUDenverGeneral@sarahcannon.com
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Weiss
Phone
203-737-3472
Email
christina.wiess@yale.edu
Facility Name
FL Cancer Specialists - Lake Mary
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Keville
Phone
407-804-6133
Email
jessica.keville@flcancer.com
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Email
clinicaltrials@igmbio.com
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Orem
Phone
502-629-2500
Ext
19471
Email
Ben.Orem@nortonhealthcare.org
Facility Name
Maryland Oncology Hematology, PA - Columbia
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Saavedra
Phone
301-933-3216
Email
teresa.saavedra@usoncology.com
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Spagnuolo
Email
ashley.spagnuolo@startmidwest.com
Facility Name
Minnesota Oncology - Minneapolis Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nykole Starks
Phone
612-884-6300
Email
nykole.starks@usoncology.com
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Timm
Phone
314-215-7337
Email
timmd@wustl.edu
Facility Name
Gabrail Cancer Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Smith
Phone
330-417-8231
Email
csmith@gabrailcancercenter.com
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Caldwell
Phone
405-271-8001
Ext
48171
Email
Christina-Caldwell@ouhsc.edu
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Email
CanClinRsrchStudies@providence.org
Facility Name
SCRI - Tennessee
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Email
DDUreferrals@sarahcannon.com
Facility Name
Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Rowan
Phone
512-421-4100
Email
jennifer.rowan@usoncology.com
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Email
referral@MaryCrowley.org
Facility Name
The University of Texas, MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bria Battle
Phone
713-792-2376
Email
BNBattle@mdanderson.org
Facility Name
Texas Oncology - San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Saenz
Email
Edward.saenz@usoncology.com
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Friedman
Phone
571-222-2200
Email
carrie.friedman@usoncology.com
Facility Name
Seattle Cancer Alliance - Fred Hutch
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaysey Orlowski
Email
korlowsk@fredhutch.org
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Parker
Phone
+61 (0)2 4228 6200
Email
suetrials@smdcc.com.au
Facility Name
Tasman Health
City
Southport
ZIP/Postal Code
QLD 4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Tasker
Email
nicole@tasmanhealthcare.com.au
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Kim
Phone
+82-2-3410-3459
Email
seungtae1.kim@samsung.com
Facility Name
Gachon University Gil Hospital
City
Gyeonggi-do
State/Province
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Contact
Phone
+82-32-460-3209
Email
sympson@gilhospital.com
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
State/Province
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Contact
Phone
+82-31-787-7039
Email
hmodoctor@snubh.org

12. IPD Sharing Statement

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Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers

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