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

NCT05601219 | Terminated Phase 1 FDA Drug

• 1 other identifier: ADA-011-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)

  36 months

• Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)

  36 months

Other Outcomes (2)

• Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011

  36 months

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  36 months

Study Arms (3)

ADA-011 Monotherapy Dose Escalation

EXPERIMENTAL

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 Monotherapy Dose Expansion

EXPERIMENTAL

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

Combination Therapy Dose Escalation

EXPERIMENTAL

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; Drug: PD(L)-1 inhibitor

Interventions

ADA-011 DRUG

ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.

ADA-011 Monotherapy Dose Escalation; ADA-011 Monotherapy Dose Expansion; Combination Therapy Dose Escalation

PD(L)-1 inhibitor DRUG

PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.

Combination Therapy Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adanate, Inc: lead

Study Sites (5)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized dose escalation followed by dose expansion.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 1, 2022
• Study Start: November 15, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (5)