Clinical trial NCT05601219: A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors
Official title: A Phase 1, Open-Label, Multicenter Study of ADA-011 as Monotherapy and in Combination With a Checkpoint Inhibitor for Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Adanate, Inc
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized dose escalation followed by dose expansion.
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: 36 months
measure: Number of Dose-Limiting Toxicities (DLTs)
timeFrame: 21 days (cycle 1)
Secondary outcomes:
measure: Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)
timeFrame: 36 months
measure: Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)
timeFrame: 36 months
Other outcomes:
measure: Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011
timeFrame: 36 months
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: 36 months
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: