A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors

Solid Tumor, Adult Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601219
• Other study ID #: ADA-011-001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Adanate, Inc
• Contact: Study Director
• Phone: (650) 732-4010
• Email: info[@]adanate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study consists of dose escalation evaluation to determine the safety and tolerability of ADA-011 as a monotherapy and in combination with a checkpoint inhibitor. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• ADA-011
ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
• PD(L)-1 inhibitor
PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	Duke University	Durham	North Carolina
United States	Florida Cancer Specialists	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Adanate, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011	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.	36 months
Other	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	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.	36 months
Primary	Number of Participants Who Experienced an Adverse Event (AE)	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.	36 months
Primary	Number of Dose-Limiting Toxicities (DLTs)	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.	21 days (cycle 1)
Secondary	Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)	Pharmacokinetic (PK) parameters of ADA-011 including area under the curve (AUC) will be evaluated for all participants in the dose escalation cohorts.	36 months
Secondary	Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)	Pharmacokinetic (PK) parameters of ADA-011 including maximum concentration (Cmax) will be evaluated for all participants in the dose escalation cohorts.	36 months