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

Phase 1

Terminated

• Conditions: Solid Tumor, Adult
• Interventions: Drug: ADA-011; Drug: PD(L)-1 inhibitor

• Registration Number: NCT05601219
• Lead Sponsor: Adanate, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-01
• Study Start: 2022-11-15
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADA-011 Monotherapy Dose Escalation	ADA-011	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.
Combination Therapy Dose Escalation	ADA-011	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.
Combination Therapy Dose Escalation	PD(L)-1 inhibitor	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.
ADA-011 Monotherapy Dose Expansion	ADA-011	ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (5)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Florida Cancer Specialists; 🇺🇸 Orlando, Florida, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States