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

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

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: ADA-011; Drug: PD(L)-1 inhibitor

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
  • Florida
    • Orlando, Florida, United States, 32827
      • Florida Cancer Specialists
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADA-011 Monotherapy Dose Escalation; ADA-011 monotherapy will be administered intravenously (IV), every 3 weeks (Q3W) at escalating doses starting with Cycle 1, Day 1, until participant withdrawal. Participants enroll with histologically or cytologically confirmed solid tumors.	Drug: ADA-011; ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
Experimental: ADA-011 Monotherapy Dose Expansion; ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.	Drug: ADA-011; ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
Experimental: Combination Therapy Dose Escalation; Combination therapy with ADA-011 and PD(L)-1 inhibitor (at escalating ADA-011 doses) will be administered IV Q3W, starting with Cycle 1, Day 1 in participants with histologically or cytologically confirmed solid tumors.	Drug: ADA-011; ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.; Drug: PD(L)-1 inhibitor; PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Adanate, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ADA-011-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No