Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers
Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma
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
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
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
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
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