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Trial Title:
A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors
NCT ID:
NCT05601219
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Non-randomized dose escalation followed by dose expansion.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ADA-011
Description:
ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
Arm group label:
ADA-011 Monotherapy Dose Escalation
Arm group label:
ADA-011 Monotherapy Dose Expansion
Arm group label:
Combination Therapy Dose Escalation
Intervention type:
Drug
Intervention name:
PD(L)-1 inhibitor
Description:
PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.
Arm group label:
Combination Therapy Dose Escalation
Summary:
This study consists of dose escalation evaluation to determine the safety and
tolerability of ADA-011 as a monotherapy. Following dose escalation, one or more dose
expansion cohorts in selected indications will be explored to further evaluate the
safety, tolerability, and preliminary efficacy of ADA-011.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically documented, incurable or metastatic solid tumor that
is advanced (nonresectable) or recurrent and progressing since the last antitumor
therapy and for which no recognized standard therapy exists
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Measurable disease per RECIST v1.1 or per other criteria best suited for the
specific tumor type being evaluated
- Adequate organ function
Exclusion Criteria:
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy,
hormonal therapy, or radiation) within 2 weeks prior to the first dose of ADA-011
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent
within 4 weeks prior to the first dose of ADA-011
- Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011
- AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for
alopecia
- Known, central nervous system (CNS) disease involvement, or prior history of NCI
CTCAE Grade ≥3 drug-related CNS toxicity.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection
- Active SARS-CoV-2 infection, irrespective of symptoms.
- History or risk of severe, chronic, untreated, or currently active autoimmune
disease
- Prior solid organ transplant or has had an allogenic hematopoietic stem cell
transplant within the past 20 years
- Pregnant, lactating, or breastfeeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
The Christ Hospital
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Start date:
November 15, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Adanate, Inc
Agency class:
Industry
Source:
Adanate, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601219
