Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma

Sponsor
Adagene (Suzhou) Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04775680
Collaborator
(none)
60
1
3
35.6
1.7

Study Details

Study Description

Brief Summary

This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.

The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).

Condition or Disease Intervention/Treatment Phase
  • Biological: ADG106 injection
  • Biological: PD-1 antibody injection
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma
Actual Study Start Date :
Mar 11, 2021
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ADG106 combined with PD-1 antibody Dose Escalation Level 1

Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle

Biological: PD-1 antibody injection
PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle

Experimental: ADG106 combined with anti PD-1 antibody Dose Escalation Level 2

Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle

Biological: PD-1 antibody injection
PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle

Experimental: ADG106 combined with anti PD-1 antibody Expansion Phase

Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle

Biological: PD-1 antibody injection
PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle

Outcome Measures

Primary Outcome Measures

  1. Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody. [From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days]

  2. Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma [From baseline to measured progressive disease (up to 24 months)]

Secondary Outcome Measures

  1. Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment [From the first dose of ADG106 and PD-1 antibody (Week 1 Day 1) to 28 days post last dose]

  2. Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf)) [From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)]

  3. Maximum (peak) plasma concentration (Cmax) [From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)]

  4. Time to maximum(peak) plasma concentration Tmax [From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)]

  5. Through plasma concentration(Cthrough) [From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)]

  6. Anti-drug antibody levels of ADG106 and PD-1 antibody [From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with advanced solid tumors or relapses/refractory non-Hodgkin's lymphoma confirmed by histology or cytology

  • Has at least one measurable lesion (solid tumor according to RECIST v1.1 criteria, non-Hodgkin's lymphoma according to Lugnao criteria)

  • ECOG score of 0 or 1;

  • Expected survival time ≥ 3 months (at the discretion of the investigator);

  • Adequate organ and bone marrow function;

  • Voluntarily sign the informed consent form;

Exclusion Criteria:
  • Has central nervous system primary malignant tumor, active epileptic seizure, spinal cord compression or carcinomatous meningitis

  • The previous anti-tumor treatment has not passed the prescribed washout period

  • HIV antibody is positive, or with other acquired/congenital immunodeficiency disease, or with history of organ transplantation;

  • Active hepatitis B or hepatitis C virus (HCV) antibody was positive;

  • Patients who are pregnant or lactating;

  • Known or suspected hypersensitivity to the study drug or its pharmaceutical excipients (including mono-hydrate citric acid, sodium di-hydrate citric acid, mannitol, polysorbate, arginine, succinic acid);

  • Any active autoimmune disease, or known history of autoimmune disease, or syndrome requiring systemic steroids or immunosuppressive medications (other than controlled thyroid disease with alternative therapy/non-immunosuppressive therapy);

  • Participation in another therapeutic or interventional clinical study in the meantime;

  • Other circumstances where the investigator considers it is not appropriate to participate in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-Sen University Cancer Center Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Adagene (Suzhou) Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adagene (Suzhou) Limited
ClinicalTrials.gov Identifier:
NCT04775680
Other Study ID Numbers:
  • ADG106-1008
First Posted:
Mar 1, 2021
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adagene (Suzhou) Limited
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022