Solid Tumor, AdultPhase 1NCT05601219
A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors
A Phase 1 study testing ADA-011 and PD(L)-1 inhibitor in people with Solid Tumor, Adult, run by Adanate, Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- ADA-011 and PD(L)-1 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Nov 2022to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Duke University
Durham, North Carolina, 27710
Florida Cancer Specialists
Orlando, Florida, 32827
Oregon Health & Science University
Portland, Oregon, 97239
HonorHealth
Scottsdale, Arizona, 85258
About this study
Official title: 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.
- Conditions
- Solid Tumor, Adult
- Being tested
- ADA-011, PD(L)-1 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADA-011Drug
ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle.
PD(L)-1 inhibitorDrug
PD(L)-1 inhibitor will be administered intravenously (IV) Q3W.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: ADA-011; Drug: PD(L)-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21 days (cycle 1)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 Nov 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Why it stopped: Internal company decision (non-safety related)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized dose escalation followed by dose expansion.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adanate, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601219
- Sponsor's protocol ID
- ADA-011-001
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05601219
- Acronym / sponsor ID
- ADA-011-001
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal company decision (non-safety related)
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Adanate, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non-randomized dose escalation followed by dose expansion.
| Arm | Type | Receives |
|---|---|---|
| ADA-011 Monotherapy Dose Escalation | Experimental | Drug: ADA-011ADA-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. |
| ADA-011 Monotherapy Dose Expansion | Experimental | Drug: ADA-011ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors. |
| Combination Therapy Dose Escalation | Experimental | Drug: ADA-011, Drug: PD(L)-1 inhibitorCombination 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADA-011ADA-011 will be administered intravenously (IV) Q3W on a 21-day cycle. | Drug | ADA-011 Monotherapy Dose Escalation, ADA-011 Monotherapy Dose Expansion, Combination Therapy Dose Escalation |
| PD(L)-1 inhibitorPD(L)-1 inhibitor will be administered intravenously (IV) Q3W. | Drug | Combination Therapy Dose Escalation |
Primary outcome
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)
Time frame: 36 months
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Internal company decision (non-safety related)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADA-011 and PD(L)-1 inhibitor in people with Solid Tumor, Adult, run by Adanate, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Internal company decision (non-safety related)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced an Adverse Event (AE) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.