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Nab paclitaxel

Phase 1

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Agenus Inc.|Last Updated: Dec 30, 2024

Target and mechanism

ModalitySmall molecule

Also known as Nab-paclitaxel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Nab paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT04827953Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic CancerPancreatic Ductal Adenocarcinoma
ACTIVE NOT_RECRUITING28 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment efficacy according to response
17 months

Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR) according to RECIST 1.1 criteria

Secondary Endpoints

Frequency of occurrence of adverse events
8 months
Treatment efficacy according to disease control rate
8 months
Treatment efficacy according to progression free survival (PFS)
8 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Investigational treatmentEXPERIMENTALConventional Chemotherapy (Gemcitabine + nab-paclitaxel) plus NLM-001 plus Zalifrelimab

Interventions

NameTypeDescription
GemcitabineDRUGGemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
Nab paclitaxelDRUGNab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
NLM-001DRUGNLM-001 will be administered three cycles consecutively followed by two rest cycles.
ZalifrelimabDRUGZalifrelimab administration each 6 weeks.
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent 2. Age ≥18 years 3. Histological or cytological diagnosis of pancreatic adenocarcinoma 4. Stage IV disease 5. No prior treatment for advanced disease. Pat...

Countries:Spain
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Frequently asked questions about Nab paclitaxel

What is Nab paclitaxel used for in Pancreatic Ductal Adenocarcinoma?

Nab paclitaxel is being studied for the treatment of Pancreatic Ductal Adenocarcinoma. It is an investigational small molecule in Phase 1 clinical development. The drug is being evaluated in combination with standard chemotherapy plus zalifrelimab in patients with advanced pancreatic cancer.

Who is developing Nab paclitaxel?

Nab paclitaxel is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AGEN. The company is conducting clinical trials to evaluate the safety and efficacy of the drug in patients with advanced pancreatic cancer.

What phase is Nab paclitaxel in?

Nab paclitaxel is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 28 patients.

What clinical trials is Nab paclitaxel in?

Nab paclitaxel is being studied in a Phase 1 clinical trial with the identifier NCT04827953. The trial is titled "Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer." The study is active but not recruiting and is being conducted in Spain.

Is Nab paclitaxel the same as Nab-paclitaxel?

Yes, Nab paclitaxel is also known as Nab-paclitaxel. Both names refer to the same drug being developed by Agenus Inc. for the treatment of Pancreatic Ductal Adenocarcinoma. The drug is currently in Phase 1 clinical trials.