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Clinical Trial 21565

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04952753

Phase: Phase II
Principal Investigator: Imanirad, Iman

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

An Open-Label, Multi-center, Phase II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations with Standard of Care (SOC) Anti-Cancer Therapy for the Second Line Treatment of Metastatic Colorectal Cancer (mCRC)

Summary

The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.

Objective

Safety Run-in (SRI) part: To confirm the recommended phase 2 dose (RP2D) of NIS793 or any other investigational drug(s), in combination with SOC anti-cancer therapy Expansion part: To evaluate preliminary efficacy of NIS793 or any other investigational drug(-s) in combination with SOC anti-cancer therapy versus SOC anti-cancer therapy in terms of progression-free survival (PFS)

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

Avastin (Bevacizumab); Bevacizumab (); FOLFIRI (); FOLFOX6 (); NIS793 (); Tislelizumab ()

Inclusion Criteria

Key Inclusion Criteria:

Participants age 18 or older with histologically or cytologically confirmed (by local laboratory and local clinical guidelines) metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery in the opinion of the investigator and progressed on or within 6 months after the last dose of one prior line of systemic anti-cancer therapy administered for metastatic disease.

Presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Adequate organ function (assessed by central laboratory for eligibility).

Other criteria apply

Exclusion Criteria

Key Exclusion Criteria:

Previously administered TGF-β targeted therapies or anti-cancer immunotherapy.

Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) mandatory, locally performed BRAFV600 mutation positive colorectal cancer.

Known complete or partial dipyrimidine dehydrogenase (DPD) enzyme deficiency (testing for DPD enzyme deficiency is not mandatory unless required by local regulations and can be conducted at a local laboratory).

For participants treated with irinotecan: Known history or clinical evidence of reduced UGT1A1 activity (testing for UGT1A1 status is not mandatory unless required by local regulations and can be conducted at a local laboratory).

Participants who have not recovered from a major surgery performed prior to start of study treatment or have had a major surgery within 4 weeks prior to start of study treatment.

Impaired cardiac function or clinically significant cardio-vascular disease.

History of positive test for human immunodeficiency virus (HIV) infection (testing is not mandatory at screening, unless required by local regulations).

Active or chronic hepatitis B virus (HBV) or hepatitis C virus infections. Note: Participants with a history of hepatitis C virus (HCV) infection must have been treated with confirmation of cure, to be considered as eligible.

Participants with conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.

Stroke or transient ischemic attack, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before start of study treatment.

Pregnant or breast-feeding women.

Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as required.

Other criteria may apply

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