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IO-202

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |cbdMD, Inc.|Last Updated: Jun 4, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

IO-202 · 1 trial · 1 indication

Phase 1 1
NCT05309187Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid TumorsSolid Tumor, Adult
COMPLETED22 Analytics
PHASE1COMPLETED
Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent and serious adverse events in patients treated with IO-202 and IO-202 + pembrolizumab
From first dose of IO-202 until the end of treatment which is up to 2 years from the first treatment date

safety and tolerability as measured by the incidence of treatment-emergent adverse events.

Dose-limiting toxicities (DLTs) with IO-202 and IO-202 + pembrolizumab
From the first dose of IO-202 and IO-202 + pembrolizumab until 21 days after 1st treatment

DLTs as measured by the incidence during Cycle 1.

Study discontinuations due to adverse events (AEs)
From the first dose of IO-202 IO-202 and IO-202 + pembrolizumab up to 2 years from the first treatment.

The number of study discontinuations due to AEs

Secondary Endpoints

Maximum serum concentration (Cmax) of IO-202
From the first dose of IO-202 until Cycle 5, Day 1
Minimum concentration of IO-202
From the first dose of IO-202 until the last treatment which is up to 2 years from the first treatment date
Immunogenicity of IO-202 and IO-202 + pembrolizumab
From the first dose until 24 months after the last treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IO-202 Monotherapy (dose escalation)EXPERIMENTAL -
IO-202 dose escalation + pembrolizumabEXPERIMENTALIncreasing dose levels of IO-202 with fixed dose of pembrolizumab
IO-202 + pembrolizumab combination therapy (dose expansion)EXPERIMENTALRP2D + pembrolizumab combination therapy in solid tumor cohorts

Interventions

NameTypeDescription
IO-202BIOLOGICALIO-202 given as monotherapy
IO-202 + pembrolizumab combination therapyBIOLOGICALIO-202 and fixed dose pembrolizumab combination therapy
RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor typesBIOLOGICALExpansion cohorts of the RP2D of IO-202 and fixed dose pembrolizumab combination therapy in multiple tumor types.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Subject must be ≥18 years old. 2. Part 1 - Dose Escalation: Subject must have any histologically or cytologically confirmed advanced or metastatic solid tumor and has received, has been intolerant to, or has been ineligible for standard systemic therapy known to confer clinic...

Countries:United States
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Frequently asked questions about IO-202

What is IO-202 used for in solid tumors?

IO-202 is an investigational monoclonal antibody being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, with a completed dose-escalation and dose-expansion study evaluating IO-202 alone and in combination with pembrolizumab in patients with solid tumors.

What does IO-202 target?

IO-202 is a monoclonal antibody designed to target a specific molecular pathway involved in solid tumor growth. The exact molecular target has not been disclosed in available clinical trial information, but the drug is being investigated for its potential to treat adult solid tumors.

Who is developing IO-202?

IO-202 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of IO-202 in patients with solid tumors.

What phase is IO-202 in?

IO-202 is in Phase 1 clinical development. A Phase 1 dose-escalation and dose-expansion study has been completed, with 22 patients enrolled. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is IO-202 in?

IO-202 has been studied in one clinical trial, registered as NCT05309187. This was a Phase 1 dose-escalation and dose-expansion study of IO-202 alone and in combination with pembrolizumab in adult patients with solid tumors. The trial was completed in the United States.

Is IO-202 the same as pembrolizumab?

No, IO-202 is not the same as pembrolizumab. IO-202 is an investigational monoclonal antibody being developed by cbdMD, Inc., while pembrolizumab is an approved immunotherapy drug. In the clinical trial NCT05309187, IO-202 was studied both alone and in combination with pembrolizumab.