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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05236608
Other study ID # STCC-02
Secondary ID CA209-63CADG106-
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 12, 2021
Est. completion date May 2024

Study information

Verified date March 2022
Source National University Hospital, Singapore
Contact Boon Cher Goh
Phone +65 6772 4617
Email boon_cher_goh@nuhs.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab
Administered together with ADG106 via intravenous infusion.
ADG106
Administered as an intravenous infusion over 90 minutes.

Locations

Country Name City State
Singapore National Cancer Centre Singapore Singapore
Singapore National University Hospital Singapore

Sponsors (4)

Lead Sponsor Collaborator
National University Hospital, Singapore Adagene Inc, Bristol-Myers Squibb, Singapore Translational Cancer Consortium

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Costantini A, Corny J, Fallet V, Renet S, Friard S, Chouaid C, Duchemann B, Giroux-Leprieur E, Taillade L, Doucet L, Nguenang M, Jouveshomme S, Wislez M, Tredaniel J, Cadranel J. Efficacy of next treatment received after nivolumab progression in patients — View Citation

Freeman AT, Lesperance M, Wai ES, Croteau NS, Fiorino L, Geller G, Brooks EG, Poonja Z, Fenton D, Irons S, Ksienski D. Treatment of non-small-cell lung cancer after progression on nivolumab or pembrolizumab. Curr Oncol. 2020 Apr;27(2):76-82. doi: 10.3747/ — View Citation

Qi X, Li F, Wu Y, Cheng C, Han P, Wang J, Yang X. Optimization of 4-1BB antibody for cancer immunotherapy by balancing agonistic strength with Fc?R affinity. Nat Commun. 2019 May 20;10(1):2141. doi: 10.1038/s41467-019-10088-1. — View Citation

Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, Azpilikueta A, Etxeberria I, Bolaños E, Lang V, Rodriguez M, Aznar MA, Jure-Kunkel M, Melero I. Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunother — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 Adverse events profile, safety profile of the combination of ADG106 and nivolumab according to the NCI Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). 45 months
Primary Objective response rate Objective response rate (CR + PR) using RECIST 1.1 of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2). 24 months
Secondary Progression free survival at 6 months Progression free survival at 6 months of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2) and the irRECIST objective response rate. 6 months
Secondary Area Under the Curve [AUC] Pharmacokinetics of nivolumab/ADG106 will be measured using blood samples collected at specify timepoint Baseline until Cycle 2 Day 1, each cycle is 21 days
Secondary Maximum Plasma Concentration [Cmax] Pharmacokinetics of nivolumab/ADG106 will be measured using blood samples collected at specify timepoint Baseline until Cycle 2 Day 1, each cycle is 21 days
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