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AVID200

Phase 1

Malignant Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 19, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

AVID200 · 2 trials · 2 indications

Phase 1 2
NCT03834662A Trial of AVID200, a Transforming Growth Factor β (TGFβ) Inhibitor, in Patients MalignanciesMalignant Solid Tumor
COMPLETED19 Analytics
NCT03831438Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic SclerosisScleroderma, Diffuse
COMPLETED9 Analytics
PHASE1COMPLETED
A Trial of AVID200, a Transforming Growth Factor β (TGFβ) Inhibitor, in Patients Malignancies
Malignant Solid TumorUnlock trial analytics
PHASE1COMPLETED
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
Scleroderma, DiffuseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, for up to 24 months

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Primary Outcome: Incidence of treatment related adverse events
10 Months

Incidence of treatment related adverse events

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Level 1: 180 mg/m2 of AVID200EXPERIMENTALIntravenous infusion of AVID200 over 1 hour administered every three weeks. Starting dose for dose escalation.
Dose Level 2: 550 mg/m2 of AVID200EXPERIMENTALIntravenous infusion of AVID200 over 1 hour administered every three weeks.
Dose Level 3: 1100 mg/m2EXPERIMENTALIntravenous infusion of AVID200 over 1.5 hours administered every three weeks.
Dose escalationOTHERSequential escalating doses of AVID200 when administered once every 2 weeks (Q2W) by 1-hour intravenous (IV) infusion to patient cohorts with diffuse cutaneous systemic sclerosis (dcSSc). Each 2-week dosing period equals 1 cycle; patients may receive up to 3 cycles of AVID200 (i.e., dosing on D1, 15, and 29 of overall 6 week treatment period).

Interventions

NameTypeDescription
AVID200DRUGA TGFβ receptor ectodomain-IgG Fc fusion protein inhibitor of TGFβ
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with a documented (histologically or cytologically proven) solid tumor malignancy that is locally advanced or metastatic * Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability o...

Countries:United StatesCanada
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Frequently asked questions about AVID200

What is AVID200 used for?

AVID200 is an investigational small molecule being studied for the treatment of diffuse cutaneous systemic sclerosis (scleroderma) and malignant solid tumors. It is in Phase 1 clinical development and has not been approved by the FDA.

What does AVID200 target?

AVID200 is a transforming growth factor beta (TGFβ) inhibitor. It is designed to block TGFβ signaling, which is implicated in fibrosis and tumor growth. This mechanism is being evaluated in clinical trials for scleroderma and cancer.

Who makes AVID200?

AVID200 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and tolerability.

What phase is AVID200 in?

AVID200 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in scleroderma and one in malignant solid tumors.

What clinical trials is AVID200 in?

AVID200 has been studied in two completed Phase 1 trials. NCT03831438 evaluated the drug in patients with diffuse cutaneous systemic sclerosis, and NCT03834662 assessed it in patients with malignant solid tumors. Both trials were conducted in the United States and Canada.

Is AVID200 the same as a TGFβ inhibitor?

Yes, AVID200 is a transforming growth factor beta (TGFβ) inhibitor. It is being investigated for its potential to treat conditions associated with fibrosis and cancer by targeting the TGFβ pathway.