Solid Tumor, AdultPhase 1NCT04306900

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

A Phase 1 study testing TTX-030, budigalimab and mFOLFOX6, TTX-030, budigalimab and docetaxel and TTX-030 and mFOLFOX6 in people with Solid Tumor, Adult, run by Trishula Therapeutics, Inc. at 32 sites in 2 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 a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. Read more about this study

Who is it for?: Ages 18 to 110 years
Conditions the study is for: Solid Tumor, Adult
What is being tested?: TTX-030, budigalimab and mFOLFOX6, TTX-030, budigalimab and docetaxel and TTX-030 and mFOLFOX6
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 32 sitesin 2 countries
Study dates: 30 Mar 2020to 27 Mar 2024
Phase: Phase 1
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 to 110 years
All sexes
No healthy volunteers
Adult, Older adult

Abbreviated Inclusion Criteria:

Age 18 years or older, is willing and able to provide informed consent
Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
Life expectancy > 12 weeks
ECOG performance status of 0-1

Abbreviated Exclusion Criteria:

History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Trial locations and contacts

32 sites in 2 countries.

Country

City, postcode or hospital

32 sites in 2 countries

United States26 sites

University of Chicago Medical Center
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44122
IACT Health - John B. Amos Cancer Center
Columbus, Georgia, 31904
City of Hope Medical Center Clinical Trials Office
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia, 22031
West Cancer Center and Research Institute
Germantown, Tennessee, 38138
Prisma-Health Cancer Institute
Greenville, South Carolina, 29605
University of Southern California
Los Angeles, California, 90007
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA Hematology/Oncology
Los Angeles, California, 90404
Norton Cancer Institute
Louisville, Kentucky, 40202
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami, Florida, 33136
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Ochsner Medical Center
New Orleans, Louisiana, 70121
Ocala Oncology Center PL
Ocala, Florida, 34474
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, 68130
Chao Family Comprehensive CC, UCI
Orange, California, 92868
Orlando Health UF Health Cancer Center
Orlando, Florida, 32835
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Hunstman Cancer Intitute
Salt Lake City, Utah, 84112
NEXT Oncology
San Antonio, Texas, 78229
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Montefiore Medical Center
The Bronx, New York, 10461
University of Toledo
Toledo, Ohio, 43614

Other trials in United States

South Korea6 sites

Samsung Medical Center
Gangnam-gu, Seoul, 06351
National Cancer Center
Ilsandong-gu, Goyang-si, Gyeonggi-do, 10408
Severance Hospital Yonsei University
Seodaemun-gu, Seoul, 03722
National Cancer Center
Seogu, Busan, 49201
Seoul National University
Seongnam-si Bundan-gu, Gyeonggi-do, 13620
Asan Medical Center
Songpa-gu, Seoul, 05505

Other trials in South Korea

About this study

Official title: Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Conditions: Solid Tumor, Adult
Being tested: TTX-030, budigalimab and mFOLFOX6, TTX-030, budigalimab and docetaxel, TTX-030 and mFOLFOX6, TTX-030 and budigalimab, TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Keywords: Gastric (gastroesophageal cancer), Advanced Solid Tumor, Colorectal cancer, Cancer, Metastatic Solid Tumor, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy Immuno-oncology, PD-1 Checkpoint Inhibitor, Docetaxel, Budigalimab, ABBV-181, TTX-030, Non-small cell lung cancer, Urothelial cell cancer, Pancreatic cancer, Pembrolizumab, Keytruda, Bladder cancer
Medical subject headings: Colorectal Neoplasms, Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Urinary Bladder Neoplasms

What participants receive

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

TTX-030, budigalimab and mFOLFOX6Combination product
Dose and schedule per protocol
TTX-030, budigalimab and docetaxelCombination product
Dose and schedule per protocol
TTX-030 and mFOLFOX6Combination product
Dose and schedule per protocol
TTX-030 and budigalimabCombination product
Dose and schedule per protocol
TTX-030, budigalimab, nab-paclitaxel and gemcitabineCombination product
Dose and schedule per protocol
TTX-030 and pembrolizumabCombination product
Dose and schedule per protocol
TTX-030, nab-paclitaxel and gemcitabineCombination product
Dose and schedule per protocol
Budigalimab and mFOLFOX6Combination product
Dose and schedule per protocol

Study groups in NCT04306900
Study group	Role	What they receive
Combo 1	Experimental	TTX-030 plus budigalimab plus mFOLFOX6 Receives: Combination Product: TTX-030, budigalimab and mFOLFOX6
Combo 2	Experimental	TTX-030 plus budigalimab plus docetaxel Receives: Combination Product: TTX-030, budigalimab and docetaxel
Combo 3	Experimental	TTX-030 plus mFOLFOX6 Receives: Combination Product: TTX-030 and mFOLFOX6
Combo 4	Experimental	TTX-030 plus pembrolizumab Receives: Combination Product: TTX-030 and pembrolizumab
Combo 5	Experimental	TTX-030 plus budigalimab (selected tumors evaluated in expansion) Receives: Combination Product: TTX-030 and budigalimab
Combo 6	Experimental	TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine Receives: Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Combo 7	Experimental	TTX-030 plus nab-paclitaxel + gemcitabine Receives: Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Combo 8	Experimental	Budigalimab plus mFOLFOX6 Receives: Combination Product: Budigalimab and mFOLFOX6

What is being measured

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

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Measured: 7 day load + 1 cycle (1 cycle is 28 days)
The Incident of Adverse Events
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Measured: Through study completion, an average of 1 year

Secondary outcomes (7)

Confirmed Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR or PR.
Measured: Through study completion, an average of 1 year
Best Response (BOR)
The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Measured: Through study completion, an average of 1 year
Duration of Response (DOR)
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
Measured: Through study completion, an average of 1 year
Progression-free Survival (PFS)
PFS is measured from documentation of progression or death from any cause, whichever occurs first
Measured: Through study completion, an average of 1 year
Overall Survival (OS)
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
Measured: Through study completion, an average of 1 year
Pharmacokinetics (PK)
Serum concentrations of TTX-030 will be tabulated
Measured: Cycles 1-4 (each cycle is 21-28 days)

Timeline

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

30 Mar 202027 Mar 2024

First posted13 Mar 2020
Study start30 Mar 2020
Primary completion30 Nov 2022
Study completion27 Mar 2024

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 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: Single group
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04306900
Sponsor's protocol ID: TTX-030-002
Status last verified: Jul 2025
First submitted: 4 Mar 2020
Last updated: 29 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04306900
Acronym / sponsor ID: TTX-030-002
Conditions: Solid Tumor, Adult
Keywords: Gastric (gastroesophageal cancer), Advanced Solid Tumor, Colorectal cancer, Cancer, Metastatic Solid Tumor, Combination Therapy, CD39, Adenosine Pathway
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Trishula Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: AbbVie
Study start: 30 Mar 2020 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 27 Mar 2024 (actual)
First posted: 13 Mar 2020 (actual)
Results: Posted 29 Jul 2025

Clinical summary

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

This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Combo 1	Experimental	Combination Product: TTX-030, budigalimab and mFOLFOX6TTX-030 plus budigalimab plus mFOLFOX6
Combo 2	Experimental	Combination Product: TTX-030, budigalimab and docetaxelTTX-030 plus budigalimab plus docetaxel
Combo 3	Experimental	Combination Product: TTX-030 and mFOLFOX6TTX-030 plus mFOLFOX6
Combo 4	Experimental	Combination Product: TTX-030 and pembrolizumabTTX-030 plus pembrolizumab
Combo 5	Experimental	Combination Product: TTX-030 and budigalimabTTX-030 plus budigalimab (selected tumors evaluated in expansion)
Combo 6	Experimental	Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabineTTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
Combo 7	Experimental	Combination Product: TTX-030, nab-paclitaxel and gemcitabineTTX-030 plus nab-paclitaxel + gemcitabine
Combo 8	Experimental	Combination Product: Budigalimab and mFOLFOX6Budigalimab plus mFOLFOX6

Who may qualify

Ages: 18 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
TTX-030, budigalimab and mFOLFOX6Dose and schedule per protocol	Combination product	Combo 1
TTX-030, budigalimab and docetaxelDose and schedule per protocol	Combination product	Combo 2
TTX-030 and mFOLFOX6Dose and schedule per protocol	Combination product	Combo 3
TTX-030 and budigalimabDose and schedule per protocol	Combination product	Combo 5
TTX-030, budigalimab, nab-paclitaxel and gemcitabineDose and schedule per protocol	Combination product	Combo 6
TTX-030 and pembrolizumabDose and schedule per protocol	Combination product	Combo 4
TTX-030, nab-paclitaxel and gemcitabineDose and schedule per protocol	Combination product	Combo 7
Budigalimab and mFOLFOX6Dose and schedule per protocol	Combination product	Combo 8

Primary outcome

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: 7 day load + 1 cycle (1 cycle is 28 days)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
The Incident of Adverse Events
Time frame: Through study completion, an average of 1 year
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

7 secondary outcomes

Confirmed Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
Best Response (BOR)
Time frame: Through study completion, an average of 1 year
Duration of Response (DOR)
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 1 year
Progression-free Survival (PFS)
Time frame: Through study completion, an average of 1 year
Overall Survival (OS)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics (PK)
Time frame: Cycles 1-4 (each cycle is 21-28 days)

Results and safety

Results posted to the registry on 29 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)	8	8
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)	44	44
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)	25	25
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)	6	6
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)	7	7
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)	28	28
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)	17	17
Cohort 4 - CRC (TTX-030 + Budigalimab)	14	14
Cohort 6 - HNSCC (TTX-030 + Budigalimab)	5	5
Cohort 8 - GEC (TTX-030 + Budigalimab)	23	23
Cohort 10 - UCC (TTX-030 + Pembrolizumab)	8	8

Primary outcome: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Time frame: 7 day load + 1 cycle (1 cycle is 28 days). Count of participants. Unit: Participants

Measure	Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6) n = 6	Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6) n = 0	Cohort 12 - Gastric (Budigalimab + mFOLFOX6) n = 0	Cohort 3A - Gastric (TTX-030 + mFOLFOX6) n = 0	Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel) n = 7	Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel) n = 0	Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel) n = 0	Cohort 4 - CRC (TTX-030 + Budigalimab) n = 0	Cohort 6 - HNSCC (TTX-030 + Budigalimab) n = 0	Cohort 8 - GEC (TTX-030 + Budigalimab) n = 0	Cohort 10 - UCC (TTX-030 + Pembrolizumab) n = 0
Value	6	0	0	0	7	0	0	0	0	0	0

Population analysed: Only Cohort 1 and Cohort 2 are the safety lead-in cohorts and were evaluated for DLTs.

Primary outcome: The Incident of Adverse Events

Time frame: Through study completion, an average of 1 year. Count of participants. Unit: Participants

Measure	Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6) n = 8	Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6) n = 44	Cohort 12 - Gastric (Budigalimab + mFOLFOX6) n = 25	Cohort 3A - Gastric (TTX-030 + mFOLFOX6) n = 6	Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel) n = 7	Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel) n = 28	Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel) n = 17	Cohort 4 - CRC (TTX-030 + Budigalimab) n = 14	Cohort 6 - HNSCC (TTX-030 + Budigalimab) n = 5	Cohort 8 - GEC (TTX-030 + Budigalimab) n = 23	Cohort 10 - UCC (TTX-030 + Pembrolizumab) n = 8
Value	8	44	25	6	7	28	17	14	5	23	8

Population analysed: This set included all participants who received at least 1 dose or any partial dose of study treatment. The Safety Analysis Set was used for safety endpoints and study treatment administration.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)	4 of 8 (50%)	8 of 8 (100%)	2 of 8
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)	27 of 44 (61.4%)	43 of 44 (97.7%)	13 of 44
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)	16 of 25 (64%)	25 of 25 (100%)	7 of 25
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)	2 of 6 (33.3%)	6 of 6 (100%)	2 of 6
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)	4 of 7 (57.1%)	7 of 7 (100%)	0 of 7
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)	16 of 28 (57.1%)	28 of 28 (100%)	11 of 28
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)	8 of 17 (47.1%)	17 of 17 (100%)	8 of 17
Cohort 4 - CRC (TTX-030 + Budigalimab)	4 of 14 (28.6%)	14 of 14 (100%)	7 of 14
Cohort 6 - HNSCC (TTX-030 + Budigalimab)	2 of 5 (40%)	1 of 5 (20%)	2 of 5
Cohort 8 - GEC (TTX-030 + Budigalimab)	10 of 23 (43.5%)	23 of 23 (100%)	10 of 23
Cohort 10 - UCC (TTX-030 + Pembrolizumab)	3 of 8 (37.5%)	8 of 8 (100%)	2 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Solid Tumor, Adult

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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.

32 sites in 2 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?

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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, 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?

Yes. Results are posted in the registry (first posted 29 Jul 2025). 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?

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: 7 day load + 1 cycle (1 cycle is 28 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 NCT04306900.

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 29 Jul 2025.