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

NCT04645069 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ADG126-1001
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 9

Brief Summary

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

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 ADG126 (Week 1 Day 1) until 21 days

• 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 Outcomes (5)

• Antidrug antibodies (ADAs)

  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)

• 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)

Study Arms (6)

ADG126 mono dose escalation

EXPERIMENTAL

ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.

Biological: ADG126 Mono

ADG126 mono dose expansion

EXPERIMENTAL

Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.

Biological: ADG126 Mono

ADG126-anti PD1 drug dose escalation

EXPERIMENTAL

Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Biological: ADG126-anti PD1

ADG126-anti PD1 drug dose expansion

EXPERIMENTAL

Combination therapy expansion will commence at RP2D or the dose approved by the SRC.

Biological: ADG126-anti PD1

ADG126-ADG106 dose escalation

EXPERIMENTAL

Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Biological: ADG126-ADG106

ADG126-ADG106 dose expansion

EXPERIMENTAL

Combination therapy expansion will commence at RP2D or the dose approved by the SRC.

Biological: ADG126-ADG106

Interventions

ADG126 Mono BIOLOGICAL

ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.

ADG126 mono dose escalation; ADG126 mono dose expansion

ADG126-anti PD1 BIOLOGICAL

ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion

ADG126-anti PD1 drug dose escalation; ADG126-anti PD1 drug dose expansion

ADG126-ADG106 BIOLOGICAL

ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion

ADG126-ADG106 dose escalation; ADG126-ADG106 dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age.
• ECOG performance status 0 or 1.
• Estimated life expectancy of more than 12 weeks .
• 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.
• At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
• Adequate organ function.
• Meets the additional tumor type requirements as specified in Protocol.

You may not qualify if:

• Treatment with any investigational drug within washout period.
• Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
• History of significant immune-mediated AE.
• Central nervous system (CNS) disease involvement.
• Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
• Clinically significant cardiac disease.
• Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
• Patients who received:
• A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
• Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
• Known active infection of HBV/BCV/HIV.
• Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
• Second primary malignancy not in remission for greater than 3 years.
• History(within the last 5 years) or risk of autoimmune disease.
• Pregnant or breastfeeding females.

Sponsors & Collaborators

• Adagene Inc: lead

Study Sites (9)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Next oncology

San Antonio, Texas, 78229, United States

Location

Southside Cancer Care Centre

Miranda, New South Wales, 2228, Australia

Location

Macquarie University Hospital

Sydney, New South Wales, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

Location

Cabrini Health Limited

Malvern, Victoria, 3144, Australia

Location

One Clinical Research Pty Ltd

Nedlands, Western Australia, 6009, Australia

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

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: November 20, 2020
• First Posted: November 27, 2020
• Study Start: March 15, 2021
• Primary Completion: January 29, 2024
• Study Completion: May 17, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

SG (2); US (2); AU (5)