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

Adanate

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: ADA-011; Drug: PD(L)-1 inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05601219

ADA-011-001

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

ADA-011 Monotherapy Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: ADA-011

ADA-011 Monotherapy Dose Expansion

Experimental group

Description:

ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.

Treatment:

Drug: ADA-011

Combination Therapy Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: PD(L)-1 inhibitor

Drug: ADA-011