Neoplasms

All Conditions

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Gland and Hormone Related Diseases

Rare Diseases

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Pancreatic Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

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Antineoplastic Agents

All Drugs and Chemicals

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Pembrolizumab

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Vaccines

Imiquimod

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients then receive imiquimod cream topically in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Beginning about 1 hour after each vaccine, patients also receive sotigalimab IV over 60 minutes on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and weeks 6,12, and 24, then every 3 months, and at week 39.

Sotigalimab

Synthetic Tumor-Associated Peptide Vaccine Therapy

Computed Tomography

Magnetic Resonance Imaging

Michael J. Overman

Michael J Overman

This phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.

PRIMARY OBJECTIVES:

I. Demonstrate that developing a custom vaccine for metastatic pancreatic ductal adenocarcinoma (PDA) and colorectal cancer (CRC) patients is feasible. (cohorts A and B)

II. Show that a custom peptide-based vaccine in combination with imiquiomod, pembrolizumab, and/or sotigalimab (APX005M) is safe. (cohorts A and B and C and D)

SECONDARY OBJECTIVES:

I. Determine the clinical benefit of the peptide vaccine alone or combined with pembrolizumab or pembrolizumab and APX005M. (cohorts A and B and C and D)

II. Demonstrate the antigenicity of each vaccine. (cohorts A and B and C and D)

III. The change in neoantigen-specific T cell responses at 12 weeks after initiation of personalized peptide vaccination. (cohorts C and D)

IV. Relapse-free survival and circulating tumor deoxyribonucleic acid (ctDNA) clearance rate. (cohorts C and D)

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT A: Patients receive personalized synthetic tumor-associated peptide vaccine therapy subcutaneously (SC) on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients then receive imiquimod cream topically in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

COHORT B: Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 12, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and at weeks 0 and 6, then every 3 months, and at week 39.

COHORTS C AND D: Patients receive personalized synthetic tumor-associated peptide vaccine therapy SC on day 1 of weeks 0, 1, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Beginning 15 minutes after each vaccine is administered, patients receive imiquimod cream topically. Patients also receive pembrolizumab IV over 30 minutes every 3 weeks until week 24 in the absence of disease progression or unacceptable toxicity. Beginning about 1 hour after each vaccine, patients also receive sotigalimab IV over 60 minutes on day 1 of weeks 0, 1, 3, 4, 6, 9, 12, 15, 18, 21, and 24 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans at baseline and weeks 6,12, and 24, then every 3 months, and at week 39.

After completion of study treatment, patients are followed for 6 months.

Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

Pilot Study of the Feasibility and Safety of a Personalized Peptide Vaccine in Patients With Advanced Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma

Defined as the proportion of subjects who experience at least one toxicity event per National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0. A toxicity event is defined as at least one grade 3 or 4 non-hematologic or grade 4 hematologic toxicity. Proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.

Progression free includes complete response (CR), partial response (PR), and stable disease (SD). The target proportion is 45%, and a proportion of 20% or lower will be considered as not having the desired efficacy.

Estimated by the Kaplan-Meier method, along with the 95% confidence intervals, and log-rank test will be used to assess the time to event variable differences under different patient subgroups.

Response rate includes both CR and PR and will be evaluated using a Simon optimal two-stage design.

A linear mixed model will also be fitted to correlate ctDNA clearance and neoantigen-specific CD8+ T cell over time.

The difference in log2 transformed T cell response from baseline to 12 weeks will be calculated for each peptide and patient. This endpoint will focus upon the log2-fold change at 12 weeks for the max peptide (i.e., the peptide with the greatest change). Descriptive statistics, including mean, standard deviation, median and range, will be used to summarize the changes. A paired t-test will be used to evaluate the changes from baseline to 12 weeks post initiation of vaccination.

Assessed by flow cytometry in response to stimulation with personalized peptide antigens.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Sotigalimab administered IV at 0.3 mg/kg every 3 weeks (21 day) treatment cycles

Sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14 day) treatment cycles

Metastatic melanoma participants who have failed any number of prior lines of therapy with minimum 3 measurable lesions.

Sotigalimab administered IV at 0.3mg/kg in combination with Stereotactic Body Radiation Therapy (SBRT) every 2 weeks (14-day) treatment cycles up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day) treatment cycles.

Sotigalimab is a CD40 agonistic monoclonal antibody

sotigalimab

This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or metastatic melanoma. Participants who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts with different sotigalimab administration schedules as long as both are open for enrollment. Participants who have failed any number of prior lines of therapy will be assigned to a 3rd cohort of sotigalimab in combination with radiation therapy.

This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of Sotigalimab administered at 2 different schedules to adult participants with unresectable or metastatic melanoma who have not received prior immunotherapy. Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as both cohorts are open.

Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Sotigalimab in combination with stereotactic body radiation therapy (SBRT) in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3: Sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

Primary Objective

• Evaluate the overall response rate (ORR) by RECIST 1.1 measurements in each of the cohorts.

Secondary Objectives

* Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort
* Evaluate ORR by modified RECIST 1.1 for immune-based therapeutics (iRECIST) in each cohort
* Evaluate median duration of response (DOR) in each cohort

Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as the cohorts are open:

Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Enrolled participants assigned to Cohorts 1 or 2 that do not receive sotigalimab or are not evaluable for tumor response will be replaced in that cohort before assigning new participants to the other cohort.

Cohort 3: Participants who have failed any number of prior lines of therapy, sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma

A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab (APX005M) With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma

The PFS was defined as the time (in months) from the first administration of APX005M to the event or censoring date. An event was defined as the first documentation of PD (disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method.

PD: \>20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The percentage of participants having reached a confirmed Complete Response (CR) or Partial Response (PR) by RECIST 1.1, relative to the number of participants belonging to the Efficacy Population. Confidence Intervals (CIs) were calculated using exact (Clopper-Pearson) method.

CR: Disappearance of all target lesions and nontarget (NT) lesions; PR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.

The percentage of participants having reached an immune confirmed Complete Response (iCR) or Partial Response (iPR) by iRECIST 1.1, relative to the number of participants belonging to the Efficacy Population. CIs were calculated using exact (Clopper-Pearson) method.

iCR: Disappearance of all target lesions and NT lesions; iPR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.

The DoR was defined as the time (in months) from the first evidence of confirmed objective response (CR or PR) to the event or censoring date. An event was defined as the first documentation of progression disease (PD; disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method.

CR: Disappearance of all target lesions and NT lesions; PR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions; PD: \>20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Apexigen America, Inc.

All AE's below are reported regardless of relationship to treatment.

Sotigalimab infusion (IV) 0.3 mg/kg every 3 weeks (21 day) treatment cycles.

Cohort 1

Sotigalimab infusion (IV) 0.3 mg/kg every 2 weeks (14 day) treatment cycles.

Cohort 2

Sotigalimab infusion (IV) 0.3 mg/kg every 2 weeks (14 day) treatment cycle plus Stereotactic Body Radiation Therapy (SBRT) every 14 day-cycles (up to 16 weeks) followed by sotigalimab every 14 days in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy.

Cohort 3

Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycle.

Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.

Participants received 0.3mg/kg of sotigalimab administered through IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Poland

Spain

Region of Enrollment

Weight

Height

ECOG Performance Status determines the ability of participants to tolerate therapies in serious illness. 0= Asymptomatic (no symptoms), 1= Symptomatic (exhibits symptoms) but completely ambulatory.

Eastern Cooperative Oncology Group (ECOG) Performance Status

The Safety Population was defined as all participants who received any sotigalimab.

Pyxis Oncology Clinical Operations

Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycles.

Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles.

Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.

Participants evaluable for efficacy (tumor response) are defined as those who have measurable disease and at least one evaluable (post baseline) tumor assessment performed during the treatment period or within 30 days after the administration of the last dose of treatment.

Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Overall Response Rate (ORR)

Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.

iORR for iRECIST 1.1 by Cohort (Efficacy Population).

Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)

PFS for RECIST 1.1 by Cohort (Efficacy Population).

RECIST 1.1 Progression-free Survival (PFS)

DoR for RECIST 1.1 by Cohort (Efficacy Population). Inclusive of participants who experienced CR or PR only.

RECIST 1.1 Duration of Response (DoR)

Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.

Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer	NCT02600949	Metastatic Colo... Metastatic Panc... Stage IV Colore... Stage IV Pancre... Stage IVA Color... Stage IVB Color...	Imiquimod Pembrolizumab Sotigalimab Synthetic Tumor... Computed Tomogr... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer	NCT02600949	Metastatic Colo... Metastatic Panc... Stage IV Colore... Stage IV Pancre... Stage IVA Color... Stage IVB Color...	Imiquimod Pembrolizumab Sotigalimab Synthetic Tumor... Computed Tomogr... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma	NCT04337931	Unresectable Me... Metastatic Mela... Cancer Cancer of Skin Melanoma Melanoma (Skin)	sotigalimab	18 Years -	Apexigen America, Inc.

Spots Global Cancer Trial Database for sotigalimab

Every month we try and update this database with for sotigalimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sotigalimab

Every month we try and update this database with for sotigalimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sotigalimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.