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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized dose escalation followed by dose expansion.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ADA-011

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

ADA-011

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

ADA-011

Intervention Type DRUG

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

PD(L)-1 inhibitor

Intervention Type DRUG

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

Interventions

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ADA-011

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

Intervention Type DRUG

PD(L)-1 inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No