HER2-positive Breast CancerPhase 3NCT04109391

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

A Phase 3 study testing TX05 (trastuzumab) and Herceptin (trastuzumab) in people with HER2-positive Breast Cancer and Early-stage Breast Cancer, run by Tanvex BioPharma USA, Inc. at 86 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer
What is being tested?: TX05 (trastuzumab) and Herceptin (trastuzumab)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 338 participants
Where: 86 sitesin 10 countries
Study dates: 20 Aug 2019to 8 Mar 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed written informed consent.
Females ≥ 18 years of age.
Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit.
Successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician.
Able to comply with the study protocol.
Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug.

Who cannot join

Breast cancer metastases or residual disease post operatively (as determined by local assessment).
History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
Lactating or pregnant female.
Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence [periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.

Trial locations and contacts

86 sites in 10 countries.

Country

City, postcode or hospital

86 sites in 10 countries

Russia24 sites

Tanvex Investigational Site 1535E
Arkhangelsk, 163045
Tanvex Investigational Site 1531E
Belgorod, 308010
Tanvex Investigational Site 1502E
Kaluga
Tanvex Investigational Site 1505E
Kislino, 305524
Tanvex Investigational Site 1529E
Krasnodar, 350040
Tanvex Investigational Site 1512E
Krasnoyarsk, 660133
Tanvex Investigational Site 1530E
Moscow, 121467
Tanvex Investigational Site 1507E
Moscow
Tanvex Investigational Site 1511E
Novosibirsk, 630099
Tanvex Investigational Site 1503E
Omsk, 644013
Tanvex Investigational Site 1509E
Omsk, 644013
Tanvex Investigational Site 1537E
Orenburg, 460021
Tanvex Investigational Site 1526E
Pesochnyy, 197758
Tanvex Investigational Site 1510E
Pushkin, 196603
Tanvex Investigational Site 1521E
Rostov-on-Don, 344037
Tanvex Investigational Site 1516E
Saint Petersburg, 191015
Tanvex Investigational Site 1523E
Saint Petersburg, 191104
Tanvex Investigational Site 1524E
Saint Petersburg, 191104
Tanvex Investigational Site 1525E
Saint Petersburg, 196247
Tanvex Investigational Site 1506E
Saint Petersburg, 197758
Tanvex Investigational Site 1501E
Saint Petersburg
Tanvex Investigational Site 1508E
Saransk, 430032
Tanvex Investigational Site 1513E
Sochi, Krasnodarskiy Kray, 354057
Tanvex Investigational Site 1534E
Yaroslavl, 150054

Other trials in Russia

Ukraine17 sites

Tanvex Investigational Site 1820E
Antonivka, 73000
Tanvex Investigational Site 1803E
Chernihiv, 14029
Tanvex Investigational Site 1808E
Chernihiv, 14029
Tanvex Investigational Site 1821E
Chernivtsi, 58013
Tanvex Investigational Site 1824E
Dnipro, 49600
Tanvex Investigational Site 1811E
Kiev, 03115
Tanvex Investigational Site 1802E
Kiev, 04107
Tanvex Investigational Site 1819E
Kropyvnytskyi, 25006
Tanvex Investigational Site 1814E
Kropyvnytskyi, 25011
Tanvex Investigational Site 1804E
Kryvyi Rih, 50048
Tanvex Investigational Site 1815E
Kyiv, 03022
Tanvex Investigational Site 1809E
Kyiv, 03126
Tanvex Investigational Site 1810E
Odesa, 65055
Tanvex Investigational Site 1806E
Sumy, 40022
Tanvex Investigational Site 1822E
Ternopil, 46023
Tanvex Investigational Site 1818E
Vinnytsia, 21029
Tanvex Investigational Site 1813E
Zaporizhzhya, 69059

Other trials in Ukraine

India10 sites

Tanvex Investigational Site 7033E
Ahmedabad, 380016
Tanvex Investigational Site 7019E
Bangalore, 560027
Tanvex Investigational Site 7022E
Belagavi, 590010
Tanvex Investigational Site 7045E
Hyderabad, 500004
Tanvex Investigational Site 7036E
Hyderabad, 500034
Tanvex Investigational Site 7006E
Kolkata, 700099
Tanvex Investigational Site 7031E
Nashik, Maharashtra, 422002
Tanvex Investigational Site 7001E
Nashik, 422002
Tanvex Investigational Site 7015E
Pune, 411001
Tanvex Investigational Site 7017E
Vijayawada, 520002

Other trials in India

Peru9 sites

Tanvex Investigational Site 1101E
Arequipa, 04001
Tanvex Investigational Site 1107E
Arequipa, 04001
Tanvex Investigational Site 1104E
Chiclayo, 14001
Tanvex Investigational Site 1105E
Lima, 15036
Tanvex Investigational Site 1112E
Lima Cercado, 15082
Tanvex Investigational Site 1108E
San Borja, 41
Tanvex Investigational Site 1102E
San Isidro, 15073
Tanvex Investigational Site 1109E
Surquillo, 15038
Tanvex Investigational Site 1103E
Trujillo, 13001

Other trials in Peru

Belarus6 sites

Tanvex Investigational Site 1006E
Grodno, 230017
Tanvex Investigational Site 1003E
Homyel, 246012
Tanvex Investigational Site 1008E
Lesnoy, 223040
Tanvex Investigational Site 1002E
Minsk, 220013
Tanvex Investigational Site 1005E
Mogilev, 212018
Tanvex Investigational Site 1001E
Vitebsk, 210603

Other trials in Belarus

Georgia6 sites

Tanvex Investigational Site 5006E
Batumi, 6000
Tanvex Investigational Site 5002E
Batumi, 6010
Tanvex Investigational Site 5001E
Tbilisi, 0159
Tanvex Investigational Site 5005E
Tbilisi, 0159
Tanvex Investigational Site 5010E
Tbilisi, 0186
Tanvex Investigational Site 5008E
Tbilisi, 112

Other trials in Georgia

Philippines6 sites

Tanvex Investigational Site 1211E
Cebu City, 6000
Tanvex Investigational Site 1212E
Davao City, 8000
Tanvex Investigational Site 1214E
Makati City, 1229
Tanvex Investigational Site 1209E
Quezon City, 1101
Tanvex Investigational Site 1213E
Quezon City, 1102
Tanvex Invesitgational Site 1210E
Santo Tomas, 4234

Other trials in Philippines

Mexico5 sites

Tanvex Investigational Site 2109E
Aguascalientes, 20234
Tanvex Investigational Site 2103E
Monterrey, 64000
Tanvex Investigational Site 2106E
Oaxaca City, 68000
Tanvex Investigational Site 2110E
Tequisquiapan, 76750
Tanvex Investigational Site 2108E
Zapopan, 45030

Other trials in Mexico

Chile2 sites

Tanvex Investigational Site 4001E
Temuco, 2520598
Tanvex Investigational Site 4002E
Viña del Mar, 4810469

Other trials in Chile

Hungary1 site

Tanvex Investigational Site 6003E
Budapest

Other trials in Hungary

About this study

Official title: A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Conditions: HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms, Stage II Breast Cancer, Stage IIIA Breast Cancer
Being tested: TX05 (trastuzumab), Herceptin (trastuzumab)
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TX05 (trastuzumab)Biological
Subjects will receive up to 13 cycles of adjuvant treatment.
Herceptin (trastuzumab)Biological
Subjects will receive up to 13 cycles of adjuvant treatment.

Study groups in NCT04109391
Study group	Role	What they receive
Test Product (TX05)	Experimental	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study. Receives: Biological: TX05 (trastuzumab)
Reference Therapy (Herceptin)	Active comparator	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive Herceptin in this extension study. Receives: Biological: Herceptin (trastuzumab)
Test Product (Herceptin/TX05 Transition)	Experimental	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study. Receives: Biological: TX05 (trastuzumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity Assessments (ADA and Nab)
Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.
Measured: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Disease-Free Survival
DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.
Measured: Through study completion/end of treatment (Week 45).
Overall Survival
OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.
Measured: Through study completion/end of treatment (Week 45).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 20198 Mar 2022

First posted30 Sep 2019
Study start20 Aug 2019
Primary completion25 Dec 2021
Study completion8 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HER2-positive Breast CancerStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 338 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04109391
Sponsor's protocol ID: TX05-03E
Status last verified: Apr 2022
First submitted: 20 Sep 2019
Last updated: 26 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HER2-positive Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
ClinicalTrials.gov ID: NCT04109391
Acronym / sponsor ID: TX05-03E
Conditions: HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms, Stage II Breast Cancer, Stage IIIA Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 338 participants (actual)
Lead sponsor: Tanvex BioPharma USA, Inc.Industry (pharma, biotech, devices)
Study start: 20 Aug 2019 (actual)
Primary completion: 25 Dec 2021 (actual)
Study completion: 8 Mar 2022 (actual)
First posted: 30 Sep 2019 (actual)
Results: Posted 26 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Test Product (TX05)	Experimental	Biological: TX05 (trastuzumab)IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
Reference Therapy (Herceptin)	Active comparator	Biological: Herceptin (trastuzumab)IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive Herceptin in this extension study.
Test Product (Herceptin/TX05 Transition)	Experimental	Biological: TX05 (trastuzumab)IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed written informed consent.
Females ≥ 18 years of age.
Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit.
Successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician.
Able to comply with the study protocol.

Key exclusion criteria (5 listed)

Breast cancer metastases or residual disease post operatively (as determined by local assessment).
History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
Lactating or pregnant female.
Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence [periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.

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
TX05 (trastuzumab)Subjects will receive up to 13 cycles of adjuvant treatment.	Biological	Test Product (Herceptin/TX05 Transition), Test Product (TX05)
Herceptin (trastuzumab)Subjects will receive up to 13 cycles of adjuvant treatment.	Biological	Reference Therapy (Herceptin)

Primary outcome

Immunogenicity Assessments (ADA and Nab)
Time frame: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.
Disease-Free Survival
Time frame: Through study completion/end of treatment (Week 45).
DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.
Overall Survival
Time frame: Through study completion/end of treatment (Week 45).
OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.

Results and safety

Results posted to the registry on 26 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product (TX05 Only)	175	165
Reference Therapy (Herceptin Only)	82	77
Test Product (Herceptin/TX05 Transition)	81	77

Primary outcome: Immunogenicity Assessments (ADA and Nab)

Time frame: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.. Count of participants. Unit: Participants

Measure	Test Product (TX05 Only) n = 175	Reference Therapy (Herceptin Only) n = 82	Test Product (Herceptin/TX05 Transition) n = 81
Baseline: ADA Positive	3	2	3
Baseline: Nab Positive	0	0	0
Baseline: ADA Negative	159	77	74
Baseline: Not evaluated	13	3	4
Cycle 6 Week 15: ADA Positive	1	1	4
Cycle 6 Week 15: Nab Positive	0	0	0
Cycle 6 Week 15: ADA Negative	164	74	74
Cycle 6 Week 15: Not evaluated	10	7	3

Primary outcome: Disease-Free Survival

Time frame: Through study completion/end of treatment (Week 45).. Count of participants. Unit: Participants

Measure	Test Product (TX05 Only) n = 175	Reference Therapy (Herceptin Only) n = 82	Test Product (Herceptin/TX05 Transition) n = 81
Recurrence of Breast Cancer or a Diagnosis of a Second Primary Cancer	6	5	3
No recurrence of Breast Cancer and No Diagnosis of a Second Primary Cancer	160	73	76
Discontinued form Study	8	4	2
No Post Baseline or No Evaluable Post Baseline	1	0	0
No Baseline or No Evaluable Baseline Assessment	0	0	0
Death	0	0	0

Primary outcome: Overall Survival

Time frame: Through study completion/end of treatment (Week 45).. Count of participants. Unit: Participants

Measure	Test Product (TX05 Only) n = 175	Reference Therapy (Herceptin Only) n = 82	Test Product (Herceptin/TX05 Transition) n = 81
Last known alive	175	82	80
Lost to Follow-Up	0	0	0
Death	0	0	1

Adverse events

Time frame: Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product (TX05 Only)	4 of 175 (2.3%)	49 of 175 (28%)	0 of 175
Reference Therapy (Herceptin Only)	3 of 82 (3.7%)	15 of 82 (18.3%)	0 of 82
Test Product (Herceptin/TX05 Transition)	2 of 81 (2.5%)	15 of 81 (18.5%)	1 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for HER2-positive Breast Cancer

RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
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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.

Bonnie Mills, PhD study director

Tanvex BioPharma USA, Inc.

86 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Russia, Ukraine, India, Peru, Belarus and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Immunogenicity Assessments (ADA and Nab) (time frame: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.). The study lists 3 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 NCT04109391.

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 26 Oct 2022.