Solid Tumor, Adult
Conditions
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.
Interventions
DRUGADA-011
ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.
Sponsors
Adanate, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-randomized dose escalation followed by dose expansion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 36 months | An AE is any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. The number of participants who discontinued study treatment due to an AE will be presented. |
| Number of Dose-Limiting Toxicities (DLTs) | 21 days (cycle 1) | DLTs will be evaluated according to NCI CTCAE v5.0 and are generally defined as grade 3 or higher toxicities which are deemed to be medically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC) | 36 months | Pharmacokinetic (PK) parameters of ADA-011 including area under the curve (AUC) will be evaluated for all participants in the dose escalation cohorts. |
| Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax) | 36 months | Pharmacokinetic (PK) parameters of ADA-011 including maximum concentration (Cmax) will be evaluated for all participants in the dose escalation cohorts. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011 | 36 months | Serum samples from participants treated with ADA-011 will be analyzed for ADA using a neutralizing antibody assay. The number of participants with neutralizing ADA will be reported. |
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 36 months | The percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 criteria will be reported. |
Countries
United States
Outcome results
None listed