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

Sponsor
National University Hospital, Singapore
Study ID
NCT05236608
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Administered together with ADG106 via intravenous infusion.
  • ADG106 — DRUG
    Administered as an intravenous infusion over 90 minutes.

Study Details

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.

Key Dates

Start date
Nov 12, 2021
Status verified
Mar 2022
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and ADG106
    Eligible patients will receive nivolumab and ADG106 by IV infusion according to the study phases below. Phase 1b: 3 evaluable patients will be treated at the starting dose, and assessed for tolerability over the first cycle. Treatment related dose-limiting toxicities (DLT) will determine the next dose level to be studied. Dose escalation will follow the 3 + 3 study dose titration design. Phase 2: The dose of ADG106 given together with nivolumab will be the recommended dose in combination with nivolumab determined in phase 1b.

Primary Outcome Measure

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: 45 months ]

Central Contacts

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