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

Phase 1

Completed

• Conditions: Advanced/Metastatic Solid Tumors
• Interventions: Biological: ADG126 Mono; Biological: ADG126-anti PD1; Biological: ADG126-ADG106

• Registration Number: NCT04645069
• Lead Sponsor: Adagene Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Study Start: 2021-03-15
• Primary Completion: 2024-01-29
• Study Completion: 2024-05-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADG126 mono dose escalation	ADG126 Mono	ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
ADG126 mono dose expansion	ADG126 Mono	Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
ADG126-anti PD1 drug dose expansion	ADG126-anti PD1	Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-ADG106 dose expansion	ADG126-ADG106	Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-anti PD1 drug dose escalation	ADG126-anti PD1	Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
ADG126-ADG106 dose escalation	ADG126-ADG106	Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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)
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)
Antidrug antibodies (ADAs)	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)

Trial Locations

Locations (9)

One Clinical Research Pty Ltd; 🇦🇺 Nedlands, Western Australia, Australia

Macquarie University Hospital; 🇦🇺 Sydney, New South Wales, Australia

Sunshine Coast University Private Hospital; 🇦🇺 Birtinya, Queensland, Australia

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Next oncology; 🇺🇸 San Antonio, Texas, United States

Cabrini Health Limited; 🇦🇺 Malvern, Victoria, Australia

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

Southside Cancer Care Centre; 🇦🇺 Miranda, New South Wales, Australia

National University Hospital; 🇸🇬 Singapore, Singapore