Clinical trial NCT04775680: Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Non Hodgkin Lymphoma
Keywords: Solid Tumor and Non Hodgkin Lymphoma
Lead sponsor: Adagene Inc
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody.
timeFrame: From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days
measure: Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma
timeFrame: From baseline to measured progressive disease (up to 24 months)
Secondary outcomes:
measure: Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment
timeFrame: From the first dose of ADG106 and PD-1 antibody (Week 1 Day 1) to 28 days post last dose
measure: Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf))
timeFrame: 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)
measure: Maximum (peak) plasma concentration (Cmax)
timeFrame: 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)
measure: Time to maximum(peak) plasma concentration Tmax
timeFrame: 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)
measure: Through plasma concentration(Cthrough)
timeFrame: 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)
measure: Anti-drug antibody levels of ADG106 and PD-1 antibody
timeFrame: 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)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
References: