Advanced/Metastatic Solid Tumors or LymphomasPhase 1NCT02675439
Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
A Phase 1 study testing ADU-S100 and ipilimumab in people with Advanced/Metastatic Solid Tumors or Lymphomas, run by Chinook Therapeutics, Inc. (formerly Aduro) at 7 sites in United States.
Trial summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors or Lymphomas
- What is being tested?
- ADU-S100 and ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Apr 2016to 6 Aug 2020
- 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
- ECOG ≤ 1
- Willing to undergo tumor biopsies from injected and distal lesions
- Must have two biopsy accessible lesions:
- * one lesion must be ≥10 mm and <100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.
- a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
- tumors encasing major vascular structures (i.e., carotid artery or tumors close to other vital organs), are not considered appropriate
Who cannot join
- Patients who require local palliative measures such as XRT or surgery
- Symptomatic or untreated leptomeningeal disease.
- Presence of symptomatic central nervous system (CNS) metastases
- Impaired cardiac function or clinically significant cardiac disease
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
- Active infection requiring systemic antibiotic therapy.
Show all 9Show fewer
- Known history of Human Immunodeficiency Virus (HIV) infection.
- Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Malignant disease, other than that being treated in this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado School of Medicine
Aurora, Colorado, 80045
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, 77030-4009
Columbia University Medical Center-Herbert Irving Pavilion
New York, New York, 10032
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.
- Being tested
- ADU-S100, ipilimumab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADU-S100Drug
Also called MIW815
ipilimumabBiological
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation monotherapy | Experimental | ADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms Receives: Drug: ADU-S100 |
| Dose escalation combination | Experimental | ADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued Receives: Drug: ADU-S100; Biological: ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Measured: 6 months from study start
Recommended dose
Using maximum tolerated dose to identify the recommended dose for future studies
Measured: 6 months from study start
Secondary outcomes (3)
Pharmacokinetics measured through plasma concentrations
measured through plasma concentrations
Measured: 6 months from study start
measurement of CD8-TIL counts
Measured: 6 months from study start
RNA expression analysis of IFN gamma and immunomodulatory genes
Measured: 6 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start28 Apr 2016
- Primary completion11 Dec 2019
- Study completion6 Aug 2020
Why it stopped: No substantial anti-tumor activity was observed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Solid Tumors or LymphomasStudies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinook Therapeutics, Inc. (formerly Aduro)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675439
- Sponsor's protocol ID
- ADU-CL-07
- Status last verified
- Dec 2021
- First submitted
- 2 Feb 2016
- Last updated
- 30 Dec 2021
- Results posted
- No
Publications
Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
PubMed 32823563
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT02675439
- Acronym / sponsor ID
- ADU-CL-07
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No substantial anti-tumor activity was observed.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Chinook Therapeutics, Inc. (formerly Aduro)Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation monotherapy | Experimental | Drug: ADU-S100ADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms |
| Dose escalation combination | Experimental | Drug: ADU-S100, Biological: ipilimumabADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG ≤ 1
- Willing to undergo tumor biopsies from injected and distal lesions
- Must have two biopsy accessible lesions:
Key exclusion criteria (9 listed)
- Patients who require local palliative measures such as XRT or surgery
- Symptomatic or untreated leptomeningeal disease.
- Presence of symptomatic central nervous system (CNS) metastases
- Impaired cardiac function or clinically significant cardiac disease
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
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 |
|---|---|---|
| ADU-S100Also: MIW815 | Drug | Dose escalation combination, Dose escalation monotherapy |
| ipilimumab | Biological | Dose escalation combination |
Primary outcome
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Time frame: 6 months from study start
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Recommended dose
Time frame: 6 months from study start
Using maximum tolerated dose to identify the recommended dose for future studies
3 secondary outcomes
Pharmacokinetics measured through plasma concentrations
Time frame: 6 months from study start
measurement of CD8-TIL counts
Time frame: 6 months from study start
RNA expression analysis of IFN gamma and immunomodulatory genes
Time frame: 6 months from study start
Results and safety
The study was stopped early (reason given: No substantial anti-tumor activity was observed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 32823563Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
Related trials for Advanced/Metastatic Solid Tumors or Lymphomas
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 1/2
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Locally Advanced Solid Tumors, Metastatic Solid Tumors
Active, not recruitingPhase 2
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
Breast Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
Lymphoma, Metastatic Malignant Solid Neoplasm
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.
7 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 ADU-S100 and ipilimumab in people with Advanced/Metastatic Solid Tumors or Lymphomas, run by Chinook Therapeutics, Inc. (formerly Aduro) at 7 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 6 inclusion and 9 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: No substantial anti-tumor activity was observed.). 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?
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (time frame: 6 months from study start). 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?
On the ClinicalTrials.gov record for NCT02675439, which also lists 1 linked publication.
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 30 Dec 2021.