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A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC

NCT05236608 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-03-25

No results posted yet for this study

Summary

This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB.

The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.

Conditions

Interventions

DRUG

Nivolumab

Administered together with ADG106 via intravenous infusion.

DRUG

ADG106

Administered as an intravenous infusion over 90 minutes.

Sponsors & Collaborators

  • Adagene Inc

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Singapore Translational Cancer Consortium

    collaborator UNKNOWN

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Boon Cher Goh · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236608 on ClinicalTrials.gov