NCT04501276

Brief Summary

This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2020

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

July 29, 2020

Last Update Submit

January 6, 2026

Conditions

Advanced/Metastatic Solid Tumors

Keywords

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors

    From first dose of ADG116 (Week 1 Day 1) until 21 days

  • Number of participants with adverse events as assessed by CTCAE v5.0

    From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose

Secondary Outcomes (6)

  • Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)

    From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)

  • Maximum (peak) plasma concentration (Cmax)

    From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  • Time to maximum (peak) plasma concentration (Tmax)

    From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  • Trough plasma concentration (Ctrough)

    From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  • Incidence of ADAs

    From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  • +1 more secondary outcomes

Study Arms (3)

Part A : Dose escalation of ADG116 monotherapy

EXPERIMENTAL
Drug: ADG116

Part B : Dose escalation of ADG116 combined with anti PD1 drug

EXPERIMENTAL
Drug: ADG116Drug: anti PD1 drug

Part C : Dose escalation of ADG116 combined with ADG106

EXPERIMENTAL
Drug: ADG116Drug: ADG106

Interventions

ADG116DRUG

For monotherapy ADG116 (Part A), ADG116 will be administered IV over 60 90 minutes until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.

Part A : Dose escalation of ADG116 monotherapyPart B : Dose escalation of ADG116 combined with anti PD1 drugPart C : Dose escalation of ADG116 combined with ADG106
ADG106DRUG

For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.

Part C : Dose escalation of ADG116 combined with ADG106
anti PD1 drugDRUG

For the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.

Part B : Dose escalation of ADG116 combined with anti PD1 drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
  • At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
  • Adequate organ function.

You may not qualify if:

  • Patients who meet any of the following criteria cannot be enrolled:
  • Pregnant or breastfeeding females.
  • Childbearing potential who does not agree to the use of contraception during the treatment period..
  • Treatment with any investigational drug within washout period.
  • Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
  • Central nervous system disease involvement
  • History or risk of autoimmune disease.
  • History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
  • Patients requiring systemic treatment with corticosteroids
  • Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
  • Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
  • Major surgery within 4 weeks prior to the first dose of the study drug.
  • Has had an allogeneic tissue/solid organ transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Next Oncology

San Antonio, Texas, 78229, United States

Location

Ashford Cancer Centre Research

Kurralta Park, Australia

Location

Cabrini Hospital

Malvern, Australia

Location

Macquarie University

Sydney, Australia

Location

Related Publications (3)

  • Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.

    PMID: 29442540BACKGROUND

  • Melero I, Hervas-Stubbs S, Glennie M, Pardoll DM, Chen L. Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer. 2007 Feb;7(2):95-106. doi: 10.1038/nrc2051.

    PMID: 17251916BACKGROUND

  • Finn OJ. Immuno-oncology: understanding the function and dysfunction of the immune system in cancer. Ann Oncol. 2012 Sep;23 Suppl 8(Suppl 8):viii6-9. doi: 10.1093/annonc/mds256.

    PMID: 22918931BACKGROUND

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 6, 2020

Study Start

September 23, 2020

Primary Completion

January 17, 2024

Study Completion

November 30, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)AU(3)