Solid TumorsPhase 1NCT02740270
Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
A Phase 1 study testing GWN323 and PDR001 in people with Solid Tumors and Lymphomas, run by Novartis Pharmaceuticals at 9 sites in 6 countries.
Trial summary
The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Lymphomas
- What is being tested?
- GWN323 and PDR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 22 Jul 2016to 3 Mar 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
- Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery.
- Histologically documented advanced or metastatic solid tumors or lymphomas
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening
- ECOG Performance Status ≤ 2.
Who cannot join
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery).
- Patients diagnosed with T-cell Lymphomas.
- Patients with prior allogenic transplants.
- Patients previously treated with anti-GITR therapy.
- History of severe hypersensitivity reactions to other mAbs.
- Patients intolerant to prior immunotherapy (unable to continue/receive due to immune-related AE).
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States4 sites
Novartis Investigative Site
Boston, Massachusetts, 02215
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
New York, New York, 10017
About this study
Official title: A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas
The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas.
This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules.
Read more
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas.
Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
- Conditions
- Solid Tumors, Lymphomas
- Being tested
- GWN323, PDR001
- Keywords
- advanced solid tumors, lymphomas, GWN323, PDR001, advanced malignancies, anti-GITR, anti-PD-1, adults
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWN323Drug
PDR001Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: GWN323 |
| Arm B | Experimental | Not described Receives: Drug: GWN323; Drug: PDR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent
Dose Limiting Toxicities
Measured: 21 days
Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents
Dose Limiting Toxicities
Measured: 42 days
Secondary outcomes (9)
Best Overall Response (BOR),
Measured: 36 months
Progression Free Survival (PFS)
per irRC and RECIST v1.1 or Cheson (2014)
Measured: 36 months
Serum concentration profiles of GWN323 as a single agent: Cmax
Measured: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax
Measured: 36 months
Presence and titer of anti-GWN323 antibodies
Measured: 36 months
Measurement of the effector/regulatory T cell ratio
Measured: at screening, 36 months
Serum concentration profiles of GWN323 as a single agent: AUC
Measured: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC
Measured: 36 months
Presence and titer of anti-PDR001 antibodies
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 posted15 Apr 2016 (estimated)
- Study start22 Jul 2016
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
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 Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740270
- Sponsor's protocol ID
- CGWN323X2101
- Other IDs
- 2015-004206-42, 2015
- Status last verified
- Feb 2021
- First submitted
- 5 Apr 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piha-Paul SA, Geva R, Tan TJ, Lim DW, Hierro C, Doi T, Rahma O, Lesokhin A, Luke JJ, Otero J, Nardi L, Singh A, Xyrafas A, Chen X, Mataraza J, Bedard PL. First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. J Immunother Cancer. 2021 Aug;9(8):e002863. doi: 10.1136/jitc-2021-002863.
PubMed 34389618
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT02740270
- Acronym / sponsor ID
- CGWN323X2101
- Conditions
- Solid Tumors, Lymphomas
- Keywords
- advanced solid tumors, lymphomas, GWN323, PDR001, advanced malignancies, anti-GITR, anti-PD-1, adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 15 Apr 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 trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas.
This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules.
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas.
Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: GWN323 |
| Arm B | Experimental | Drug: GWN323, Drug: PDR001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery.
- Histologically documented advanced or metastatic solid tumors or lymphomas
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening
- ECOG Performance Status ≤ 2.
Key exclusion criteria (7 listed)
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery).
- Patients diagnosed with T-cell Lymphomas.
- Patients with prior allogenic transplants.
- Patients previously treated with anti-GITR therapy.
- History of severe hypersensitivity reactions to other mAbs.
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 |
|---|---|---|
| GWN323 | Drug | Arm A, Arm B |
| PDR001 | Drug | Arm B |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent
Time frame: 21 days
Dose Limiting Toxicities
Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents
Time frame: 42 days
Dose Limiting Toxicities
9 secondary outcomes
Best Overall Response (BOR),
Time frame: 36 months
Progression Free Survival (PFS)
Time frame: 36 months
Serum concentration profiles of GWN323 as a single agent: Cmax
Time frame: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax
Time frame: 36 months
Presence and titer of anti-GWN323 antibodies
Time frame: 36 months
Measurement of the effector/regulatory T cell ratio
Time frame: at screening, 36 months
Serum concentration profiles of GWN323 as a single agent: AUC
Time frame: 36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC
Time frame: 36 months
Presence and titer of anti-PDR001 antibodies
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 34389618Piha-Paul SA, Geva R, Tan TJ, Lim DW, Hierro C, Doi T, Rahma O, Lesokhin A, Luke JJ, Otero J, Nardi L, Singh A, Xyrafas A, Chen X, Mataraza J, Bedard PL. First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. J Immunother Cancer. 2021 Aug;9(8):e002863. doi: 10.1136/jitc-2021-002863.
- Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GWN323 and PDR001 in people with Solid Tumors and Lymphomas, run by Novartis Pharmaceuticals at 9 sites in 6 countries.
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 7 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, Israel, Japan, Singapore and 1 more country. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent (time frame: 21 days). 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 NCT02740270, 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 21 Feb 2021.