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HCD122

Phase 1

Follicular Lymphoma | Small molecule | Oncology |Novartis AG|Trials Updated: Dec 17, 2020

HCD122 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Apr 2005

HCD122 target and mechanism

ModalitySmall molecule

Also known as Lucatumumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment145

FDA Designations

No designations recorded

HCD122 clinical trials

HCD122 · 3 trials · 4 indications

Phase 1 3
NCT01275209Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular LymphomaFollicular Lymphoma
COMPLETED1 Analytics
NCT00670592Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior TherapiesNon-Hodgkin's Lymphoma
COMPLETED111 Analytics
NCT00231166Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple MyelomaMultiple Myeloma
COMPLETED33 Analytics
PHASE1COMPLETED
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
Follicular LymphomaUnlock trial analytics
PHASE1COMPLETED
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
Non-Hodgkin's LymphomaUnlock trial analytics
PHASE1COMPLETED
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence rate of dose-limiting toxicities and adverse events
2 years
Primary endpoints (phase I) - Incidence rate of DLT and AE
2 years
Primary endpoint (phase II) - Response rate
2 years
Safety, pharmacokinetics and pharmacodynamics at multiple doses
At the completion of each dose escalation cohort

Secondary Endpoints

Response rate
2 years
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
2 years
Clinical response after various doses
Once a month
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HCD122EXPERIMENTAL -

Interventions

NameTypeDescription
HCD122DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization \[REAL/WHO\] classification * Documented CD40+ follicular lymphoma * Measurable lesion * Refractory to rituximab * Prior treatment with at least 1 chemothe...

Countries:United StatesAustraliaBelgiumCanadaFranceItalySpainGermanyHong KongSingaporeSouth KoreaUnited Kingdom
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Frequently asked questions about HCD122

What is HCD122 used for?

HCD122 is an investigational drug being studied for use in multiple myeloma, non-Hodgkin's lymphoma, and follicular lymphoma. It is in Phase 1 clinical development for these oncology indications.

What does HCD122 target?

HCD122 is a monoclonal antibody that targets CD40, as indicated by its study in CD40+ rituximab-refractory follicular lymphoma. It is being developed as a potential treatment for certain B-cell malignancies.

Who makes HCD122?

HCD122 is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is HCD122 in?

HCD122 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for multiple myeloma, non-Hodgkin's lymphoma, and follicular lymphoma.

What clinical trials is HCD122 in?

HCD122 has been studied in three completed Phase 1 trials: NCT00231166 in multiple myeloma, NCT00670592 in non-Hodgkin's or Hodgkin's lymphoma, and NCT01275209 in follicular lymphoma. These trials were open-label and uncontrolled.

Is HCD122 the same as lucatumumab?

Yes, HCD122 is also known as lucatumumab. The clinical trial NCT01275209 refers to HCD122 (Lucatumumab) in its title, confirming that both names refer to the same investigational drug.