IGM-8444 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Cancer+9 MoreIGM-8444 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stomach Cancer
  • Chronic Lymphocytic Leukemia
  • Colorectal Cancer
  • Solid Tumors
  • Sarcoma
  • Acute Myeloid Leukemia
  • Small Lymphocytic Lymphoma
  • Chondrosarcoma
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 16 Secondary · Reporting Duration: Study duration of approximately 36 months

4 weeks
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
Recommended Phase 2 Dose (RP2D) of IGM-8444 as a single agent as single agent and in combination with FOLFIRI +/- bevacizumab, IGM-8444 in combination with birinapant, and IGM-8444 in combination with venetoclax
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
Month 6
Area Under the Curve (AUC) of IGM-8444
Clearance (CL) of IGM-8444
Ph1a: Area Under the Curve (AUC) of IGM-8444
Ph1a: Clearance (CL) of IGM-8444
Ph1a: Volume of distribution (V) of IGM-8444
Volume of distribution (V) of IGM-8444
Day 28
Adverse Events of IGM-8444 as a single agent as single agent and in combination with FOLFIRI +/- bevacizumab, IGM-8444 in combination with birinapant, and IGM-8444 in combination with venetoclax
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
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
Ph1b: Adverse events of IGM-8444 + FOLFIRI ± bevacizumab
Month 36
Duration of Response (DoR)
Objective Response Rate (ORR)
Ph1a and Ph1b: Duration of Response (DoR)
Ph1a and Ph1b: Overall Survival (OS)
Ph1a and Ph1b: Progression-Free Survival (PFS)
Ph1a: Objective Response Rate (ORR)
Ph1b: Objective Response Rate (ORR)
Progression-Free Survival (PFS)
Month 6
Immunogenicity
Ph1a: Immunogenicity

Trial Safety

Safety Progress

1 of 3

Trial Design

23 Treatment Groups

Ph1b: FOLFIRI ± Bevacizumab
1 of 23
Ph1a: IGM-8444 + Venetoclax Escalation and Expansion
1 of 23
Ph1a: IGM-8444 + Docetaxel + Gemcitabine Escalation and Expansion
1 of 23
Ph1a: IGM-8444 + Birinapant Escalation and Expansion
1 of 23
Ph1a: IGM-8444 + FOLFIRI ± bevacizumab Escalation and Expansion
1 of 23
Ph1a: IGM-8444 Single Agent Alternate Dosing Escalation
1 of 23
Ph1b: IGM-8444 + FOLFIRI ± Bevacizumab
1 of 23
Ph1a: IGM-8444 + Venetoclax + Azacitidine Escalation and Expansion
1 of 23
IGM-8444 + Venetoclax Escalation and Expansion
1 of 23
IGM-8444 + FOLFIRI ± bevacizumab Escalation and Expansion
1 of 23
IGM-8444 + Docetaxel + Gemcitabine Escalation and Expansion
1 of 23
IGM-8444 + Birinapant Escalation and Expansion
1 of 23
IGM-8444 + Venetoclax + Azacitidine Escalation and Expansion
1 of 23
IGM-8444 + Birinapant Escalation
1 of 23
IGM-8444 Single Agent Expansion
1 of 23
IGM-8444 + Venetoclax Escalation
1 of 23
IGM-8444 + FOLFIRI Escalation
1 of 23
IGM-8444 Single Agent Alternate Dosing Escalation
1 of 23
IGM-8444 + FOLFIRI Expansion
1 of 23
IGM-8444 Single Agent Escalation
1 of 23
IGM-8444 + Venetoclax Expansion
1 of 23
IGM-8444 + FOLFIRI + Bevacizumab (and approved biosimilars) Expansion
1 of 23
IGM-8444 + Birinapant Expansion
1 of 23

Experimental Treatment

430 Total Participants · 23 Treatment Groups

Primary Treatment: IGM-8444 · No Placebo Group · Phase 1

Ph1b: FOLFIRI ± BevacizumabExperimental Group · 2 Interventions: FOLFIRI, Bevacizumab (and approved biosimilars) · Intervention Types: Drug, Drug
Ph1a: IGM-8444 + Venetoclax Escalation and ExpansionExperimental Group · 2 Interventions: IGM-8444, Venetoclax · Intervention Types: Drug, Drug
Ph1a: IGM-8444 + Docetaxel + Gemcitabine Escalation and ExpansionExperimental Group · 3 Interventions: Gemcitabine, Docetaxel, IGM-8444 · Intervention Types: Drug, Drug, Drug
Ph1a: IGM-8444 + Birinapant Escalation and ExpansionExperimental Group · 2 Interventions: Birinapant, IGM-8444 · Intervention Types: Drug, Drug
Ph1a: IGM-8444 + FOLFIRI ± bevacizumab Escalation and ExpansionExperimental Group · 3 Interventions: FOLFIRI, IGM-8444, Bevacizumab (and approved biosimilars) · Intervention Types: Drug, Drug, Drug
Ph1a: IGM-8444 Single Agent Alternate Dosing Escalation
Drug
Experimental Group · 1 Intervention: IGM-8444 · Intervention Types: Drug
Ph1b: IGM-8444 + FOLFIRI ± BevacizumabExperimental Group · 3 Interventions: FOLFIRI, IGM-8444, Bevacizumab (and approved biosimilars) · Intervention Types: Drug, Drug, Drug
Ph1a: IGM-8444 + Venetoclax + Azacitidine Escalation and ExpansionExperimental Group · 3 Interventions: Azacitidine, IGM-8444, Venetoclax · Intervention Types: Drug, Drug, Drug
IGM-8444 + Venetoclax Escalation and ExpansionExperimental Group · 2 Interventions: IGM-8444, Venetoclax · Intervention Types: Drug, Drug
IGM-8444 + FOLFIRI ± bevacizumab Escalation and ExpansionExperimental Group · 3 Interventions: FOLFIRI, IGM-8444, Bevacizumab (and approved biosimilars) · Intervention Types: Drug, Drug, Drug
IGM-8444 + Docetaxel + Gemcitabine Escalation and ExpansionExperimental Group · 3 Interventions: Gemcitabine, Docetaxel, IGM-8444 · Intervention Types: Drug, Drug, Drug
IGM-8444 + Birinapant Escalation and ExpansionExperimental Group · 2 Interventions: Birinapant, IGM-8444 · Intervention Types: Drug, Drug
IGM-8444 + Venetoclax + Azacitidine Escalation and ExpansionExperimental Group · 3 Interventions: Azacitidine, IGM-8444, Venetoclax · Intervention Types: Drug, Drug, Drug
IGM-8444 + Birinapant EscalationExperimental Group · 2 Interventions: Birinapant, IGM-8444 · Intervention Types: Drug, Drug
IGM-8444 Single Agent Expansion
Drug
Experimental Group · 1 Intervention: IGM-8444 · Intervention Types: Drug
IGM-8444 + Venetoclax EscalationExperimental Group · 2 Interventions: IGM-8444, Venetoclax · Intervention Types: Drug, Drug
IGM-8444 + FOLFIRI EscalationExperimental Group · 2 Interventions: FOLFIRI, IGM-8444 · Intervention Types: Drug, Drug
IGM-8444 Single Agent Alternate Dosing Escalation
Drug
Experimental Group · 1 Intervention: IGM-8444 · Intervention Types: Drug
IGM-8444 + FOLFIRI ExpansionExperimental Group · 2 Interventions: FOLFIRI, IGM-8444 · Intervention Types: Drug, Drug
IGM-8444 Single Agent Escalation
Drug
Experimental Group · 1 Intervention: IGM-8444 · Intervention Types: Drug
IGM-8444 + Venetoclax ExpansionExperimental Group · 2 Interventions: IGM-8444, Venetoclax · Intervention Types: Drug, Drug
IGM-8444 + FOLFIRI + Bevacizumab (and approved biosimilars) ExpansionExperimental Group · 3 Interventions: FOLFIRI, IGM-8444, Bevacizumab (and approved biosimilars) · Intervention Types: Drug, Drug, Drug
IGM-8444 + Birinapant ExpansionExperimental Group · 2 Interventions: Birinapant, IGM-8444 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Gemcitabine
2017
Completed Phase 3
~2850
Docetaxel
1995
Completed Phase 4
~8840
Azacitidine
2012
Completed Phase 3
~1660
Birinapant
Not yet FDA approved
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study duration of approximately 36 months

Who is running the clinical trial?

IGM Biosciences, Inc.Lead Sponsor
4 Previous Clinical Trials
390 Total Patients Enrolled
Eric Humke, MD, PhDStudy DirectorIGM Biosciences

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically documented locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
For combination cohorts, patients must be eligible to receive the chemotherapy or targeted agent.
You have no symptoms or signs of cancer.
You have received a chemotherapeutic agent or small molecule inhibitor (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Florida Cancer Specialists100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%