A Phase 1 interventional study of Aplitabart (IGM-8444) and FOLFIRI in Solid Tumor, Colorectal Cancer and Non Hodgkin Lymphoma, sponsored by IGM Biosciences, Inc.. Terminated at 58 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by IGM Biosciences, Inc. · Phase 1, Interventional, and Treatment
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.
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 272 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →IGM Biosciences, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.
Drug: Aplitabart (IGM-8444)
Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.
Drug: Aplitabart (IGM-8444) · Drug: FOLFIRI · Drug: Bevacizumab (and approved biosimilars)
Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously.
Drug: Aplitabart (IGM-8444) · Drug: Birinapant
Aplitabart will be administered intravenously in combination with Venetoclax.
Drug: Aplitabart (IGM-8444) · Drug: Venetoclax
Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine.
Drug: Aplitabart (IGM-8444) · Drug: Gemcitabine · Drug: Docetaxel
Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine.
Drug: Aplitabart (IGM-8444) · Drug: Venetoclax · Drug: Azacitidine
Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab
Drug: Aplitabart (IGM-8444) · Drug: FOLFIRI · Drug: Bevacizumab (and approved biosimilars)
Standard of Care FOLFIRI + bevacizumab will be administered intravenously
Drug: FOLFIRI · Drug: Bevacizumab (and approved biosimilars)
DR5 Agonist Investigational Drug
Chemotherapy Regimen
Also known as: Fluorouracil or 5-FU, Leucovorin, Irinotecan
Drug page: Bevacizumab
Targeted Therapy
Also known as: Avastin
SMAC-mimetic Investigational Drug
Targeted Therapy
Also known as: Venclexta
Chemotherapy
Also known as: Gemzar
Chemotherapy
Also known as: Taxotere, Docefrez
Chemotherapy
Also known as: VIDAZA
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
Time frame: 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.
Time frame: 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.
Time frame: Study duration of approximately 36 months
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.
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
Clearance (CL) of aplitabart 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
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.
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
Maximum Concentration of aplitabart 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
Ph1a and Ph1b: Immunogenicity
Immunogenicity as assessed by detection of anti-drug antibodies (ADAs) to aplitabart
Time frame: through end of treatment at approximately 6 months
Ph1a and Ph1b: Objective Response Rate (ORR)
Preliminary efficacy of objective response rate (ORR)
Time frame: Study duration of approximately 36 months
Ph1a and Ph1b: Duration of Response (DoR)
Preliminary efficacy of duration of response (DoR)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From Cycle 1 Day 1 through 28 days after the final dose of study drug
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Jan 2025, 51 months.
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab
IGM Biosciences, Inc.