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Advaxis (ADXS)
OTHER OTC:ADXS
Pembrolizumab, Adxs-503
Lung Cancer, Non-Small Cell, Metastatic Squamous Cell Carcinoma, Metastatic Non-Squamous Cell Carcinoma
Phase I/II
Completed
Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer
Jan 08, 2019
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Pembrolizumab, Adxs-Neo
Metastatic Melanoma, Urothelial Carcinoma, Metastatic Non-Small Cell Lung Cancer, Colon Cancer Metastatic, Head And Neck Cancer Metastatic
Phase I
Terminated
A Study of ADXS-NEO Expressing Personalized Tumor Antigens
Jul 12, 2017
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Adxs11-001
High Risk Cervical Cancer, Advanced Cervical Cancer
Phase III
Terminated
Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer
Jul 28, 2016
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Axalimogene Filolisbac
Rectal Cancer, Anal Cancer
Phase II
Completed
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
Mar 23, 2015
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Adxs31-164
Her2 Expressing Solid Tumors
Phase I/II
Completed
Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
Feb 26, 2015
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Pemetrexed, Adxs11-001
Carcinoma, Non-small-cell Lung
Phase II
Withdrawn
A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus Positive (HPV+), NSCLC Following First-Line Induction Chemotherapy
Feb 26, 2015
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Pembrolizumab, Adxs31-142
Cancer, Prostate Cancer
Phase I/II
Completed
ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Dec 22, 2014
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Medi4736, Adxs11-001
Cancer, Cervical Cancer, Head And Neck Cancer
Phase I/II
Terminated
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
Nov 06, 2014
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Axalimogene Filolisbac
Effects Of Immunotherapy, Metastatic/Recurrent Cervical Cancer, Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Cervical Small Cell Carcinoma, Stage Iii Cervical Cancer, Stage Iva Cervical Cancer, Stage Ivb Cervical Cancer
Phase I
Completed
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
Jun 13, 2014
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Adxs11-001 (Lm-Llo-E7)
Cervical Intraepithelial Neoplasia
Phase II
Terminated
An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
Apr 20, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Advaxis (ADXS) have in its pipeline
ADXS is currently developing the following drugs: Pembrolizumab, Adxs-503, Pembrolizumab, Adxs-Neo, Adxs11-001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.