Solid TumorPhase 1NCT04553692
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
A Phase 1 study testing Aplitabart (IGM-8444), FOLFIRI and Bevacizumab (and approved biosimilars) in people with Solid Tumor and Colorectal Cancer, run by IGM Biosciences, Inc. at 58 sites in 5 countries.
Trial summary
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma
- What is being tested?
- Aplitabart (IGM-8444), FOLFIRI and Bevacizumab (and approved biosimilars)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 58 sitesin 5 countries
- Study dates
- 23 Sep 2020to 20 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, participants must be eligible to receive the chemotherapy or targeted agent.
- Ph1a only: No more than three prior therapeutic regimens.
- Ph1b only: Must be FOLFIRI naïve participants and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting - OR - FOLFIRI naïve participants that only received adjuvant therapy who progressed within six months after completing adjuvant therapy, and are confirmed to have locally advanced/metastatic disease
Who cannot join
- 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.
Show all 10Show fewer
- Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants 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: Participants who have previously received FOLFIRI treatment in the adjuvant, advanced, or metastatic disease setting
Trial locations and contacts
58 sites in 5 countries.
58 sites in 5 countries
United States37 sites
Texas Oncology - Austin
Austin, Texas, 78705
Gabrail Cancer Research
Canton, Ohio, 44718
Maryland Oncology Hematology, PA - Columbia
Columbia, Maryland, 21044
Mary Crowley Cancer Research
Dallas, Texas, 75230
US Oncology - Dallas
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
SCRI at Healthone
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
US Oncology- Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
START Midwest
Grand Rapids, Michigan, 49546
The University of Texas, MD Anderson
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Ochsner Cancer
Jefferson, Louisiana, 70121
FL Cancer Specialists - Lake Mary
Lake Mary, Florida, 32746
Cancer and Blood Specialty Clinic (CBSC)
Los Alamitos, California, 90720
USC Norris
Los Angeles, California, 90033
UCLA
Los Angeles, California, 90404
Norton Cancer Institute
Louisville, Kentucky, 40241
Minnesota Oncology - Minneapolis Clinic
Minneapolis, Minnesota, 55404
Mayo Clinic
Minneapolis, Minnesota, 55905
SCRI - Tennessee
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
US Oncology- Virginia Oncology - Norfolk
Norfolk, Virginia, 23502
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
UC Irvine Manchester Pavilion
Orange, California, 92868
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
Mayo Clinic
Phoenix, Arizona, 85054
Providence Portland Medical Center
Portland, Oregon, 97213
Texas Oncology - San Antonio Northeast
San Antonio, Texas, 78217
UCSF
San Francisco, California, 94143
Florida Cancer Specialists
Sarasota, Florida, 34232
Seattle Cancer Alliance - Fred Hutch
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Texas Oncology - Tyler
Tyler, Texas, 75702
Australia6 sites
Napean Cancer Care
Kingswood, 2747
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3052
Tasman Health
Southport, QLD 4215
Westmead
Westmead, New South Wales, 2145
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
Queen Elizabeth Hospital
Woodville South, 5011
South Korea6 sites
Gachon University Gil Hospital
Gyeonggi-do, Seongnam-si, 13620
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, 13620
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Asan Medical Center
Seoul, 03080
Seoul National University Hospital
Seoul, 03080
Severance Hospital - Yonsei Cancer Center
Soeul
France5 sites
Institut Bergonié
Bordeaux, 33076
Centre Georges Francois Leclerc
Dijon, 21000
Saint Louis Hospital
Paris, 75010
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
Gustave Roussy
Villejuif, 94805
Spain4 sites
Vall d'Hebron Institut d'Oncologia
Barcelona, 08035
Clinica Universidad de Navarra
Madrid, 28027
Madrid FJD
Madrid, 28040
Madrid CIOCC - HM Universitario Sanchinnarro
Madrid, 28050
About this study
Official title: An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) As a Single Agent and in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.
Read the detailed description
Participants will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. Aplitabart 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 participants may be enrolled in Phase 1b, an open-label, randomized study of aplitabart+FOLFIRI+ bevacizumab.
Aplitabart 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).
Aplitabart will be administered intravenously (IV).
An alternative dosing schedule may be evaluated.
- Conditions
- Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma
- Being tested
- Aplitabart (IGM-8444), FOLFIRI, Bevacizumab (and approved biosimilars), Birinapant, Venetoclax
- Keywords
- Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Hematological cancer, Newly diagnosed
- Medical subject headings
- Colorectal Neoplasms, Lymphoma, Non-Hodgkin, Sarcoma, Chondrosarcoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Acute, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aplitabart (IGM-8444)Drug
DR5 Agonist Investigational Drug
FOLFIRIDrug
Also called Fluorouracil or 5-FU, Leucovorin, Irinotecan
Chemotherapy Regimen
Bevacizumab (and approved biosimilars)Drug
Also called Avastin
Targeted Therapy
BirinapantDrug
SMAC-mimetic Investigational Drug
VenetoclaxDrug
Also called Venclexta
Targeted Therapy
GemcitabineDrug
Also called Gemzar
Chemotherapy
DocetaxelDrug
Also called Taxotere, Docefrez
Chemotherapy
AzacitidineDrug
Also called VIDAZA
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Ph1a: Aplitabart Single Agent Alternate Dosing Escalation | Experimental | Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule. Receives: Drug: Aplitabart (IGM-8444) |
| Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion | Experimental | Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab. Receives: Drug: Aplitabart (IGM-8444); Drug: FOLFIRI; Drug: Bevacizumab (and approved biosimilars) |
| Ph1a: Aplitabart + Birinapant Escalation and Expansion | Experimental | Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously. Receives: Drug: Aplitabart (IGM-8444); Drug: Birinapant |
| Ph1a: Aplitabart + Venetoclax Escalation and Expansion | Experimental | Aplitabart will be administered intravenously in combination with Venetoclax. Receives: Drug: Aplitabart (IGM-8444); Drug: Venetoclax |
| Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion | Experimental | Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine. Receives: Drug: Aplitabart (IGM-8444); Drug: Gemcitabine; Drug: Docetaxel |
| Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion | Experimental | Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine. Receives: Drug: Aplitabart (IGM-8444); Drug: Venetoclax; Drug: Azacitidine |
| Ph1b: Aplitabart + FOLFIRI + Bevacizumab | Experimental | Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab Receives: Drug: Aplitabart (IGM-8444); Drug: FOLFIRI; Drug: Bevacizumab (and approved biosimilars) |
| Ph1b: FOLFIRI + Bevacizumab | Experimental | Standard of Care FOLFIRI + bevacizumab will be administered intravenously Receives: Drug: FOLFIRI; Drug: Bevacizumab (and approved biosimilars) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
Measured: From Cycle 1 Day 1 through 28 days after the final dose of study drug
Ph1a: To identify the recommended expansion dose for aplitabart as single agent, with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
Relationship between aplitabart dose and safety, PK, activity, and endpoints.
Measured: 4 weeks
Ph1b: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Measured: Study duration of approximately 36 months
Secondary outcomes (10)
Ph1a and Ph1b: Area Under the Curve (AUC) of aplitabart
Area Under the Curve (AUC) of aplitabart as a single agent and in combination with the anticancer agents listed above.
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Clearance (CL) of aplitabart
Clearance (CL) of aplitabart as a single agent and in combination with the anticancer agents listed above.
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Volume of distribution (V) of aplitabart
Volume of distribution (V) of aplitabart as a single agent and in combination with the anticancer agents listed above.
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Maximum Concentration (c-max) of aplitabart
Maximum Concentration of aplitabart as a single agent and in combination with the anticancer agents listed above.
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Immunogenicity
Immunogenicity as assessed by detection of anti-drug antibodies (ADAs) to aplitabart
Measured: through end of treatment at approximately 6 months
Ph1a and Ph1b: Objective Response Rate (ORR)
Preliminary efficacy of objective response rate (ORR)
Measured: Study duration of approximately 36 months
Ph1a and Ph1b: Duration of Response (DoR)
Preliminary efficacy of duration of response (DoR)
Measured: Study duration of approximately 36 months
Ph1a: Progression-Free Survival (PFS)
PFS is defined as the time from first dose (Ph1a) to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Measured: Study duration of approximately 36 months
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
Measured: Study duration of approximately 36 months
Ph1b: Adverse events of aplitabart + FOLFIRI + bevacizumab
Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
Measured: From Cycle 1 Day 1 through 28 days after the final dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start23 Sep 2020
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Study terminated due strategic corporate pivot to focus on auto-immune indications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Humke, MD, PhD, Study director, IGM Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553692
- Sponsor's protocol ID
- IGM-8444-001
- Status last verified
- Mar 2025
- First submitted
- 4 Sep 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) As a Single Agent and in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
- ClinicalTrials.gov ID
- NCT04553692
- Acronym / sponsor ID
- IGM-8444-001
- Conditions
- Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma
- Keywords
- Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Hematological cancer, Newly diagnosed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due strategic corporate pivot to focus on auto-immune indications
- Enrolment
- 272 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.
Detailed description
Participants will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. Aplitabart 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 participants may be enrolled in Phase 1b, an open-label, randomized study of aplitabart+FOLFIRI+ bevacizumab.
Aplitabart 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).
Aplitabart will be administered intravenously (IV).
An alternative dosing schedule may be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Ph1a: Aplitabart Single Agent Alternate Dosing Escalation | Experimental | Drug: Aplitabart (IGM-8444)Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule. |
| Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion | Experimental | Drug: Aplitabart (IGM-8444), Drug: FOLFIRI, Drug: Bevacizumab (and approved biosimilars)Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab. |
| Ph1a: Aplitabart + Birinapant Escalation and Expansion | Experimental | Drug: Aplitabart (IGM-8444), Drug: BirinapantAplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously. |
| Ph1a: Aplitabart + Venetoclax Escalation and Expansion | Experimental | Drug: Aplitabart (IGM-8444), Drug: VenetoclaxAplitabart will be administered intravenously in combination with Venetoclax. |
| Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion | Experimental | Drug: Aplitabart (IGM-8444), Drug: Gemcitabine, Drug: DocetaxelAplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine. |
| Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion | Experimental | Drug: Aplitabart (IGM-8444), Drug: Venetoclax, Drug: AzacitidineAplitabart will be administered intravenously in combination with Venetoclax and Azacitidine. |
| Ph1b: Aplitabart + FOLFIRI + Bevacizumab | Experimental | Drug: Aplitabart (IGM-8444), Drug: FOLFIRI, Drug: Bevacizumab (and approved biosimilars)Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab |
| Ph1b: FOLFIRI + Bevacizumab | Experimental | Drug: FOLFIRI, Drug: Bevacizumab (and approved biosimilars)Standard of Care FOLFIRI + bevacizumab will be administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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, participants must be eligible to receive the chemotherapy or targeted agent.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aplitabart (IGM-8444)DR5 Agonist Investigational Drug | Drug | Ph1a: Aplitabart + Birinapant Escalation and Expansion, Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion, Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion, Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion, Ph1a: Aplitabart + Venetoclax Escalation and Expansion, Ph1a: Aplitabart Single Agent Alternate Dosing Escalation, Ph1b: Aplitabart + FOLFIRI + Bevacizumab |
| FOLFIRIAlso: Fluorouracil or 5-FU, Leucovorin, IrinotecanChemotherapy Regimen | Drug | Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion, Ph1b: Aplitabart + FOLFIRI + Bevacizumab, Ph1b: FOLFIRI + Bevacizumab |
| Bevacizumab (and approved biosimilars)Also: AvastinTargeted Therapy | Drug | Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion, Ph1b: Aplitabart + FOLFIRI + Bevacizumab, Ph1b: FOLFIRI + Bevacizumab |
| BirinapantSMAC-mimetic Investigational Drug | Drug | Ph1a: Aplitabart + Birinapant Escalation and Expansion |
| VenetoclaxAlso: VenclextaTargeted Therapy | Drug | Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion, Ph1a: Aplitabart + Venetoclax Escalation and Expansion |
| GemcitabineAlso: GemzarChemotherapy | Drug | Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion |
| DocetaxelAlso: Taxotere, DocefrezChemotherapy | Drug | Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion |
| AzacitidineAlso: VIDAZAChemotherapy | Drug | Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion |
Primary outcome
Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
Time frame: From Cycle 1 Day 1 through 28 days after the final dose of study drug
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 aplitabart as single agent, with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
Time frame: 4 weeks
Relationship between aplitabart dose and safety, PK, activity, and endpoints.
Ph1b: Progression-Free Survival (PFS)
Time frame: Study duration of approximately 36 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
10 secondary outcomes
Ph1a and Ph1b: Area Under the Curve (AUC) of aplitabart
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Clearance (CL) of aplitabart
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Volume of distribution (V) of aplitabart
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Maximum Concentration (c-max) of aplitabart
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
Ph1a and Ph1b: Immunogenicity
Time frame: through end of treatment at approximately 6 months
Ph1a and Ph1b: Objective Response Rate (ORR)
Time frame: Study duration of approximately 36 months
Ph1a and Ph1b: Duration of Response (DoR)
Time frame: Study duration of approximately 36 months
Ph1a: Progression-Free Survival (PFS)
Time frame: Study duration of approximately 36 months
Ph1a and Ph1b: Overall Survival (OS)
Time frame: Study duration of approximately 36 months
Ph1b: Adverse events of aplitabart + FOLFIRI + bevacizumab
Time frame: From Cycle 1 Day 1 through 28 days after the final dose of study drug
Results and safety
The study was stopped early (reason given: Study terminated due strategic corporate pivot to focus on auto-immune indications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Humke, MD, PhD study director
IGM Biosciences
58 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aplitabart (IGM-8444), FOLFIRI and Bevacizumab (and approved biosimilars) in people with Solid Tumor and Colorectal Cancer, run by IGM Biosciences, Inc. at 58 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Australia, South Korea, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due strategic corporate pivot to focus on auto-immune indications). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel (time frame: From Cycle 1 Day 1 through 28 days after the final dose of study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.