Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (NUMANTIA)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    24
  • sponsor
    Nelum Corp
Updated on 8 March 2022

Summary

In order to improve the survival rates and decrease progression of pancreatic advanced cancer, this study aims to evaluate the first line treatment approved for this disease (gemcitabine plus nab-paclitaxel) in combination with two experimental drugs, an inhibitor of the signaling pathway of Hedgehog and an immunotherapy drug able of blocking the CTLA-4 receptor.

Description

Pancreatic cancer is one of the leading neoplasms in the world in terms of mortality, with very low survival rates mainly due to its rapid progression and diagnosis in advanced stages, which makes its treatment extremely difficult.

Gemcitabine plus nab-paclitaxel is currently considered the first-line standard treatment for advanced pancreatic cancer due to this superiority against other treatments.

In order to find an alternative to improve survival of advanced pancreatic cancer, this study aims to evaluate the efficacy with first-line treatment in combination of two experimental drugs, a Hedgehog pathway inhibitor (NLM-001) and a CTLA-4 blocker (zalifrelimab) in previously untreated patients with advanced pancreatic cancer.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment Gemcitabine, nab paclitaxel, NLM-001, Zalifrelimab
Clinical Study IdentifierNCT04827953
SponsorNelum Corp
Last Modified on8 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent
Age ≥18 years
Histological or cytological diagnosis of pancreatic adenocarcinoma
Stage IV disease
No prior treatment for advanced disease. Patients who have received chemotherapy for localize disease are eligible if at least six months have elapsed from the last chemotherapy treatment
Measurable disease per RECIST 1.1 as determined by the investigator
ECOG (Eastern Cooperative Oncology Group) PS 0-1
Sufficient hematopoietic, renal and liver function as defined as
Neutrophil count ≥ 1.5 x 109 / L
Platelet count ≥ 100 x 109 / L
Bilirubin ≤ 1.5 x ULN (upper limit of normal)
AST and / or ALT ≤2.5 x ULN or ≤5 for patients with liver disease
Serum creatinine ≤ 1.5 x ULN
Tumor lesion amenable for safe repeated biopsy
Women of child-bearing age and men who wish to participate in the study must agree to use appropriate contraceptive methods from the signing of informed consent until 3 months after discontinuation of the study drug
Adequate contraception includes abstinence, oral contraceptives, transdermal patches, and injections that prolong release of a progestogen (starting at least 4 weeks prior to the administration of the investigational drug), double barrier method: condom or female condom (diaphragm or condom / vaginal) plus spermicide, intrauterine device (IUD), implant or a vaginal ring (placed at least 4 weeks prior to administration of investigational drug) or male partner sterilization (vasectomy with documentation of azoospermia) before the inclusion of the woman in the trial if the male is the only sex partner of the woman
Investigators must ensure that patients recruited will be able to meet all study
requirements, including tumor biopsy, chemotherapy and monitoring

Exclusion Criteria

Active or uncontrolled infection, disease or serious medical condition that may
interfere with the patient's eligibility or treatment
Concurrent antineoplastic therapy
History of psychiatric condition that would compromise the patient's ability to
Pregnant or lactating women
understand or comply with the requirements of the protocol, or the ability to provide
informed consent
History of life-threatening serious adverse events to Gemcitabine or Nab-Paclitaxel
Prior chemotherapy or chemo-radiation therapy for advanced pancreatic cancer
Patients requiring or being treated with potent CYP3A4 inhibitors and inducers
History of allergic reactions attributed to compounds of similar chemical structure or
similar biological study drug composition
History of interstitial lung disease
Other malignancies treated within the last 5 years, except in situ cervix carcinoma or
nonmelanoma skin cancer
Subjects with a history or presence of a known clotting disorder or difficulty
achieving haemostasis will be excluded
Primary or secondary immunodeficiency, including immunosuppressive disease or
autoimmune disease (including autoimmune endocrinopathies)
Note: Subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid
disease not requiring immunosuppressive treatment are eligible. Subjects with Type 2
diabetes mellitus are allowed
Use of an inhaled or topical corticosteroid is permitted
Subjects with a known history of human immunodeficiency virus 1 and 2, human T
lymphotropic virus 1
Administration of anticancer medications or investigational drugs within the following
intervals before the first administration of study drug
A 1-week washout is permitted for palliative radiation to non- central nervous
system (CNS) disease, with medical monitor approval. Subjects must also not have
Concurrent participation in other investigational drug trials
had radiation pneumonitis as a result of treatment and cannot participate in the
study if they are on chronic corticosteroids for radiation pneumonitis Note
Bisphosphonates and denosumab are permitted medications
≤7 days for prior corticosteroid treatment, with the following exceptions
Corticosteroid premedication for radiographic imaging for dye allergies is
permitted
Use of physiologic corticosteroid replacement therapy may be approved after
consultation with the medical monitor
≤7 days for immunosuppressive-based treatment for any reason, with the exceptions
noted above for prior corticosteroid treatment
≤21 days or 5 half-lives before first dose of study treatment for all other
investigational study drugs or devices. For investigational agents with long
half-lives (e.g., >5 days), enrollment before the fifth half-life requires
medical monitor approval
Has not recovered to grade ≤1 from toxic effects of prior therapy and/or complications
from prior surgical intervention before starting therapy Note: Subjects with grade ≤2
neuropathy and alopecia are an exception and may enroll
History or presence of an abnormal ECG that, in the investigator's opinion, is
clinically meaningful
Known central nervous system (CNS) involvement as follows
Untreated CNS metastases
Leptomeningeal metastases. Note: Patients may be eligible if CNS metastases have
been treated and patients have neurologically returned to baseline (except for
residual signs and symptoms related to the CNS treatment)
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