NON-breast HER2+ MalignanciesPhase 1NCT03696771
Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
A Phase 1 study testing NJH395 in people with NON-breast HER2+ Malignancies, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
Trial summary
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NON-breast HER2+ Malignancies
- What is being tested?
- NJH395
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 27 Dec 2018to 19 Oct 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
- Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer
- Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 who have progressed or are intolerant to all approved therapies known to confer clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient 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 prior to therapy, and during therapy on this study.
Who cannot join
- History of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody.
- Patients previously treated with TLR 7/8 agonist.
- Impaired cardiac function or history of clinically significant cardiac disease
- Active, known or suspected autoimmune disease.
- Human Immunodeficiency virus (HIV) infection
- History of or current interstitial lung disease or pneumonitis Grade 2 or greater.
Show all 9Show fewer
- Discontinued prior checkpoint inhibitor due to a checkpoint inhibitor related toxicity.
- Currently receiving medications known to cause Torsades de Pointe that cannot be discontinued 7 days prior to starting treatment
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
Read the detailed description
This study has two parts. There will be a single dose of NJH395 in the first part and multiple doses of NJH395 in the second part. After the first part is completed, the second part may open.
- Conditions
- NON-breast HER2+ Malignancies
- Being tested
- NJH395
- Keywords
- Phase I, NJH395, HER2+, ISAC, TLR7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NJH395Drug
Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent
| Study group | Role | What they receive |
|---|---|---|
| NJH395 | Experimental | Includes non-breast HER2-positive advanced malignancies Receives: Drug: NJH395 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose limiting toxicities (DLTs)
The time frame will expand to 42 days for the second part of the study
Measured: 21 days
Number of participants with Adverse Events
Measured: 2.5 years
Secondary outcomes (9)
Concentration versus time profiles for NJH395 and its catabolite
Measured: 126 days
PK parameter (Cmax) for NJH395
Measured: 126 days
Pharmacokinetic (PK) parameter (AUC) for NJH395
Measured: 126 days
Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab
Measured: 126 days
Overall Response Rate
Response assessed by RECIST v1.1 and iRECIST
Measured: 2.5 years
Clinical Benefit Rate (CBR)
Response assessed by RECIST v1.1 and iRECIST
Measured: 2.5 years
Progression Free Survival (PFS)
Time from start of treatment to date of the first documented progression or death in months
Measured: 2.5 years
Duration of Response (DOR)
Response assessed by RECIST v1.1 and iRECIST
Measured: 2.5 years
Characterization of tumor-infiltrating lymphocytes by IHC
Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8).
Measured: Cycle 1 Day 5, Cycle 2 Day 1 (each cycle is 21 days), Cycle 8 Day 1 and at end of treatment (expected between months 6 and 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start27 Dec 2018
- Primary completion19 Oct 2020
- Study completion19 Oct 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 NON-breast HER2+ MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696771
- Sponsor's protocol ID
- CNJH395X2101
- Status last verified
- Jan 2022
- First submitted
- 4 Sep 2018
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janku F, Han SW, Doi T, Amatu A, Ajani JA, Kuboki Y, Cortez A, Cellitti SE, Mahling PC, Subramanian K, Schoenfeld HA, Choi SM, Iaconis LA, Lee LH, Pelletier MR, Dranoff G, Askoxylakis V, Siena S. Preclinical Characterization and Phase I Study of an Anti-HER2-TLR7 Immune-Stimulator Antibody Conjugate in Patients with HER2+ Malignancies. Cancer Immunol Res. 2022 Dec 2;10(12):1441-1461. doi: 10.1158/2326-6066.CIR-21-0722.
PubMed 36129967
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03696771
- Acronym / sponsor ID
- CNJH395X2101
- Conditions
- NON-breast HER2+ Malignancies
- Keywords
- Phase I, NJH395, HER2+, ISAC, TLR7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 5 Oct 2018 (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.
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
Detailed description
This study has two parts. There will be a single dose of NJH395 in the first part and multiple doses of NJH395 in the second part. After the first part is completed, the second part may open.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NJH395 | Experimental | Drug: NJH395Includes non-breast HER2-positive advanced malignancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer
- Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 who have progressed or are intolerant to all approved therapies known to confer clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient 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 prior to therapy, and during therapy on this study.
Key exclusion criteria (9 listed)
- History of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody.
- Patients previously treated with TLR 7/8 agonist.
- Impaired cardiac function or history of clinically significant cardiac disease
- Active, known or suspected autoimmune disease.
- Human Immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| NJH395Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent | Drug | NJH395 |
Primary outcome
Incidence and severity of dose limiting toxicities (DLTs)
Time frame: 21 days
The time frame will expand to 42 days for the second part of the study
Number of participants with Adverse Events
Time frame: 2.5 years
9 secondary outcomes
Concentration versus time profiles for NJH395 and its catabolite
Time frame: 126 days
PK parameter (Cmax) for NJH395
Time frame: 126 days
Pharmacokinetic (PK) parameter (AUC) for NJH395
Time frame: 126 days
Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab
Time frame: 126 days
Overall Response Rate
Time frame: 2.5 years
Clinical Benefit Rate (CBR)
Time frame: 2.5 years
Progression Free Survival (PFS)
Time frame: 2.5 years
Duration of Response (DOR)
Time frame: 2.5 years
Characterization of tumor-infiltrating lymphocytes by IHC
Time frame: Cycle 1 Day 5, Cycle 2 Day 1 (each cycle is 21 days), Cycle 8 Day 1 and at end of treatment (expected between months 6 and 7)
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 4 Feb 2022.
- Derived from this study: PubMed 36129967Janku F, Han SW, Doi T, Amatu A, Ajani JA, Kuboki Y, Cortez A, Cellitti SE, Mahling PC, Subramanian K, Schoenfeld HA, Choi SM, Iaconis LA, Lee LH, Pelletier MR, Dranoff G, Askoxylakis V, Siena S. Preclinical Characterization and Phase I Study of an Anti-HER2-TLR7 Immune-Stimulator Antibody Conjugate in Patients with HER2+ Malignancies. Cancer Immunol Res. 2022 Dec 2;10(12):1441-1461. doi: 10.1158/2326-6066.CIR-21-0722.
- Plain language summaries are available on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for NON-breast HER2+ Malignancies
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Breast Cancer, Gastric Cancer
RecruitingPhase 2
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NJH395 in people with NON-breast HER2+ Malignancies, run by Novartis Pharmaceuticals at 4 sites in 4 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 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: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Italy, Japan, South Korea. 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 and severity of dose limiting toxicities (DLTs) (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 NCT03696771, 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 4 Feb 2022.