ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors

Advanced/Metastatic Solid Tumors Clinical Trial

Official title:

A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645069
• Other study ID #: ADG126-1001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Adagene Inc
• Contact: Xiaohong She
• Phone: 4088389296
• Email: kristine_she[@]adagene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .

Description:

ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Adults =18 years of age.

2. ECOG performance status 0 or 1.

3. Estimated life expectancy of more than 12 weeks .

4. Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or for whom no further standard therapy exists.

5. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.

6. Adequate organ function.

7. Meets the additional tumor type requirements as specified in Protocol.

Exclusion Criteria:

1. Treatment with any investigational drug within washout period.

2. Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)

3. History of significant immune-mediated AE.

4. Central nervous system (CNS) disease involvement.

5. Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation

6. Clinically significant cardiac disease.

7. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.

8. Patients who received:

1. A COVID-19 vaccine within 7 days of Cycle 1 Day 1.

2. Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.

9. Known active infection of HBV/BCV/HIV.

10. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).

11. Second primary malignancy not in remission for greater than 3 years.

12. History(within the last 5 years) or risk of autoimmune disease.

13. Pregnant or breastfeeding females.

14. Childbearing potential who does not agree to the use of contraception during the treatment period.

Related Conditions & MeSH terms

• Advanced/Metastatic Solid Tumors
• Neoplasms

Intervention

Biological:
• ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
• ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
• ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion

Locations

Country	Name	City	State
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Cabrini Health Limited	Malvern	Victoria
Australia	Southside Cancer Care Centre	Miranda	New South Wales
Australia	One Clinical Research Pty Ltd	Nedlands	Western Australia
Australia	Macquarie University Hospital	Sydney	New South Wales
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
United States	University of California Los Angeles	Los Angeles	California
United States	Next oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Adagene Inc

Countries where clinical trial is conducted

United States,  Australia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors		From first dose of ADG126 (Week 1 Day 1) until 21 days
Primary	Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens		From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Secondary	Antidrug antibodies (ADAs)		From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary	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)
Secondary	Maximum (peak) plasma concentration (Cmax)		From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary	Time to maximum (peak) plasma concentration (Tmax)		From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary	Trough plasma concentration (Ctrough)		From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)