Combination of Nelmastobart and Capecitabine Therapy in Metastatic Colorectal Cancer

NCT05990543 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: NelCap001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label clinical trial aimed at evaluating the safety and efficacy of the combination treatment of nelmastobart with capecitabine in patients diagnosed with metastatic or recurrent colorectal cancer.

Conditions

Recurrent or Metastatic Colorectal Cancer

Keywords

colorectal cancer; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose

  The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.

  Up to approximately 2 years

• Progression free survival

  PFS events is defined as the interval from the first dose of investigational treatment to the earlier of the first documentation of objective progressive disease (PD) or death from any cause,whichever comes first.

  Up to approximately 2 years

Secondary Outcomes (2)

• Overall response rate

  Up to approximately 2 years

• Overall survival

  Up to approximately 2 years

Study Arms (1)

Group 1

EXPERIMENTAL

Nelmastobart + Capecitabine

Drug: Nelmastobart and Capecitabine

Interventions

Nelmastobart and Capecitabine DRUG

Nelmastobart intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered on Day 1 of each cycle. Capecitabine is administered orally for two weeks followed by a one-week rest period

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject ≥18 years of age at the time of signing the informed consent form (ICF).
• Subjects with histologically or cytologically confirmed colorectal adenocarcinoma who have failed or are ineligible for oxaliplatin and irinotecan-based chemotherapy.
• Subjects with advanced/metastatic solid tumors, with evaluable lesion as determined by Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
• Measurable lesion is optional.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.
• Adequate organ and bone marrow function characterized by the following at screening:
• Absolute neutrophil count(ANC) ≥1.0 × 109/L;b.
• Platelets ≥75 × 109/L;c.
• Hemoglobin ≥9.0 g/dL (with or without blood transfusions).
• Adequate renal function defined by Serum creatinine ≤ ULN x 1.5 or an estimated creatinine clearance ≥30 mL/min according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance, or according to local institutional standard method.
• Serum total bilirubin ≤2.0 x upper limit normal (ULN), if a subject with biliary obstruction is considered suitable if they meet the criteria after appropriate bile drainage.
• ALT and AST ≤ 3 × ULN, or ≤5 × ULN in the presence of liver metastases.
• Adequate cardiac function: QTc ≤480 msec; if QTc exceeds 480 msec, subjects can be enrolled if the average QTc value is less than 480 msec by measuring 3 times consecutively in total.
• The subject is able to swallow and retain oral medication
• Serum β hCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only)

You may not qualify if:

• Patient has a known or suspicious hypersensitivity to fluoropyrimidines.
• Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last dose.
• Uncontrolled severe infection
• Subjects with conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded, all of the following will not be excluded:
• Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care.
• Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.
• Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Subjects who are pregnant or breastfeeding women.
• History of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Subjects with vitiligo, psoriasis not requiring systemic treatment, type 1 diabetes mellitus, hypothyroidism stable with hormone replacement, Sjögren's syndrome, or resolved childhood asthma/atopy will not be excluded.
• Active central nervous system (CNS) lesions (i.e., those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without steroid therapy and the evidence of CNS disease progression for more than 4 weeks. However, patients with leptomeningeal metastases are excluded.
• Subjects with a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to screening.
• Subjects with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan.
• Subjects who have received a prior allogeneic stem cell or solid organ transplant.
• Subjects who have received a live attenuated vaccine within 30 days prior to screening. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• History of other primary cancer. Exceptions are as follows:

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Medical Center 73, Goryeodae-ro, Seongbuk-gu

Seoul, Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Recurrence; Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: January 29, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)