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Monoclonal Antibodies

APX005M for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Parker Institute for Cancer Immunotherapy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year from initiation of study therapy
Awards & highlights

Study Summary

This trial is testing two different drug combinations to see how well they work in treating pancreatic cancer that has spread.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year from initiation of study therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from initiation of study therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1-year Overall Survival Rate
Phase 1b Primary Safety Outcome
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR): DLT-Evaluable Population
Duration of Response (DOR): Efficacy Population
+3 more

Side effects data

From 2020 Phase 1 & 2 trial • 140 Patients • NCT03123783
67%
Decreased appetite
67%
Chills
67%
Anaemia
67%
Fatigue
67%
Vomiting
67%
Oedema peripheral
67%
Pyrexia
67%
Dry skin
33%
Lung infection
33%
Hyperglycaemia
33%
Pain
33%
Diarrhoea
33%
Lymphocyte count decrease
33%
Weight increased
33%
Blister
33%
Arthralgia
33%
Hypotension
33%
Acute kidney injury
33%
Rash maculo-papular
33%
Skin infection
33%
Skin hypopigmentation
33%
Headache
33%
Alanine aminotransferase increased
33%
Back pain
33%
Myalgia
33%
Atrial Fibrillation
33%
Dehydration
33%
Autoimmune hepatitis
33%
Blood alkaline phosphatase increased
33%
Pneumonia
33%
Optic ischaemic neuropathy
33%
Insomnia
33%
Contusion
33%
Nausea
33%
Hyperhidrosis
33%
Flushing
33%
Haematuria
33%
Aspartate aminotransferase increased
33%
Tachycardia
33%
Abdominal pain
33%
Cytokine release syndrome
33%
Weight decreased
33%
Dizziness
33%
Cough
33%
Nasal congestion
33%
Pruritus
33%
Rash
33%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3
Cohort 3B(Arm)/ PD1-NSCLC (Phase 2)
Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3
DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)
DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 3A(Arm)/ PD1-NSCLC (Phase 2)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Gem/NP/nivolumab/APX005MExperimental Treatment4 Interventions
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M
Group II: Gem/NP/nivolumabExperimental Treatment3 Interventions
Gemcitabine+Nab-Paclitaxel+nivolumab
Group III: Gem/NP/APX005MExperimental Treatment3 Interventions
Gemcitabine+Nab-Paclitaxel+APX005M
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Gemcitabine
2017
Completed Phase 3
~2070
APX005M
2017
Completed Phase 2
~350
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
511 Total Patients Enrolled
Parker Institute for Cancer ImmunotherapyLead Sponsor
9 Previous Clinical Trials
311 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,335 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Cancer LettersJournal
Prevailing over T Cell Exhaustion: New Developments in the Immunotherapy of Pancreatic Cancer
Bauer, Christian, Benjamin Kühnemuth, Peter Duewell, Steffen Ormanns, Thomas Gress, and Max Schnurr. 2016. “Prevailing over T Cell Exhaustion: New Developments in the Immunotherapy of Pancreatic Cancer”. Cancer Letters. Elsevier BV. doi:10.1016/j.canlet.2016.02.057.
New England Journal of MedicineJournal
Safety, Activity, and Immune Correlates of Anti–pd-1 Antibody in Cancer
Topalian, Suzanne L., F. Stephen Hodi, Julie R. Brahmer, Scott N. Gettinger, David C. Smith, David F. McDermott, John D. Powderly, et al.. 2012. “Safety, Activity, and Immune Correlates of Anti–pd-1 Antibody in Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1200690.
New England Journal of MedicineJournal
Increased Survival in Pancreatic Cancer with Nab-paclitaxel Plus Gemcitabine
Von Hoff, Daniel D., Thomas Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey Infante, Malcolm Moore, Thomas Seay, et al.. 2013. “Increased Survival in Pancreatic Cancer with Nab-paclitaxel Plus Gemcitabine”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1304369.
Nature Reviews CancerJournal
The Blockade of Immune Checkpoints in Cancer Immunotherapy
Pardoll, Drew M.. 2012. “The Blockade of Immune Checkpoints in Cancer Immunotherapy”. Nature Reviews Cancer. Springer Science and Business Media LLC. doi:10.1038/nrc3239.
~17 spots leftby Apr 2025
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