A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma (KISIMA-02)

Amal Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Drug: ATP150

Drug: ATP152

Drug: ATP162

Drug: Ezabenlimab

Drug: VSV-GP154

Study type

Interventional

Funder types

Industry

Identifiers

NCT05846516

KISIMA-02

Details and patient eligibility

About

This study is open to adult with Pancreatic Ductal Adenocarcinoma (PDAC). The purpose of this study is to find out whether a medicine called KISIMA-02 can help people with PDAC when taken alone or in combination with a medicine called Ezabenlimab.

KISIMA-02 is given to humans for the first time, and it is a therapeutic protein vaccine (ATP150/ATP152/ATP162) and a viral vector VSV-GP154.

Ezabenlimab is a type of antibody that may help the immune system fight cancer (checkpoint inhibitor).

There are 3 parts of the study: Part A, Part B and Part C. The main research objective in Part A and Part B is to find the highest dose of KISIMA-02 that people with PDAC can tolerate.

The main research objective in Part C is to check whether KISIMA-02 has an impact in preventing a possible reappearance of the tumor.

Participants visit the site study site regularly. The number of study visits vary based on the study Part. For one (1) of the visits, participants stay overnight for one (1) night at the study site. The doctors regularly check the participants' health and monitor the tumor. The doctors also take note of any health problems that could have been caused by the medicines.

Full description

This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab.

COMPLETED - Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment

ONGOING - Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment Cohort B1, B2, B3, B4: dose escalation

NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP162, and VSV-GP154 treatment in combination with Ezabenlimab. (treatment versus observational arm)

Enrollment

94 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria

Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
ECOG performance status of 0 or 1.
Patients with advanced or metastatic disease who completed at least 16 weeks of standard of care systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
No evidence of disease progression or recurrence.
Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as adjuvant, neoadjuvant, or perioperative (Part C)
Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
Archival tumor tissue availability for central KRAS analysis and research.

Key exclusion criteria

Not yet recovered from surgery (resected PDAC).
Gastro-intestinal bowel obstruction.
Other malignancy within the last 3 years.
Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
Prior radiotherapy within 14 days (advanced/metastatic PDAC). No prior radiotherapy. in resected PDAC
Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
Chronic systemic treatment with steroids or other immunosuppressive medications.
Active autoimmune disease requiring systemic treatment within the last 2 years.
Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment
Major (according to the Investigator's judgment) surgery within 12 weeks from initiation of study treatment
Use of Tamoxifen within 1 month prior to start of study treatment

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

94 participants in 4 patient groups

Cohort A

Experimental group

Treatment:

Drug: VSV-GP154

Drug: ATP152

Drug: ATP150

Cohort B

Experimental group

Treatment:

Drug: Ezabenlimab

Drug: VSV-GP154

Drug: ATP152

Drug: ATP150

Cohort C Treatment

Experimental group

Treatment:

Drug: Ezabenlimab

Drug: VSV-GP154

Drug: ATP162

Cohort C Observational

No Intervention group

Trial contacts and locations

Central trial contact

AMAL Therapeutics

Data sourced from clinicaltrials.gov

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