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HCD122

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1

FDA Designations

No designations recorded

Clinical trial landscape

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 Lymphoma
NCT012752091
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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 Lymphoma
NCT00670592111
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PHASE1COMPLETED
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
Multiple Myeloma
NCT0023116633
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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 the treatment of Non-Hodgkin's Lymphoma, Follicular Lymphoma, and Multiple Myeloma. It is in Phase 1 clinical development for these oncology indications.

Who makes HCD122?

HCD122 is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers.

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. All completed trials for HCD122 were Phase 1 studies.

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 conducted across multiple countries.

Is HCD122 the same as Lucatumumab?

Yes, HCD122 is also known as Lucatumumab. In clinical trial NCT01275209, the drug is referred to as HCD122 (Lucatumumab), confirming that these names refer to the same investigational agent.