CancerPhase 1NCT07424547
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing SYS6043 in people with Cancer and Solid Tumor Cancer, run by Conjupro Biotherapeutics, Inc. at 5 sites in United States.
Trial summary
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer
- What is being tested?
- SYS6043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Mar 2026to Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Major:
- Aged ≥18 years old (on the date of signing the ICF).
- Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.
- Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.
- Expected life expectancy of ≥ 3 months.
- ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.
- LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.
Who cannot join
- Major:
- Prior B7-H3 targeted therapy.
- Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).
- Symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) or a history of severe arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment.
- Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to >470 ms.
Show all 15Show fewer
- Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.
- History of interstitial lung disease (e.g., ILD/non-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening.
- History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen.
- Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
- Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.
- Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies/mL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation)..
- HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies/mL (500 IU/mL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be <2000 IU/mL before the first dose. Participants who are HBsAg-positive and/or HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study.
- Lactating women (women who are willing to temporarily discontinue breastfeeding will also be excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.
- Presence of spinal cord compression or clinically active brain metastasis, and/or meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
NEXT Oncology Austin
Austin, Texas, 78758
Dr Sahota, Principal Investigator, 210-580-9500
Dr Sahota
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Dr Salkeni, Principal Investigator, 210-580-9500
Dr Salkeni
- Recruiting
BRCR Global
Plantation, Florida, 33322
Dr Sawhney, Principal Investigator, 561-447-0614
Dr Sawhney
- Recruiting
Florida Clinical Trials Group
Plantation, Florida, 33322
Dr Amin, Principal Investigator, 772-297-3057
Dr Amin
- Recruiting
NEXT Oncology San Antonio
San Antonio, Texas, 78229
Dr Sommerhaulder, Principal Investigator, 210-580-9500
Dr Sommerhalder
About this study
Official title: Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works.
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment.
- Have safety follow-up (SFU), and long-term follow-up.
- Be followed until progression.
Read the detailed description
This is a multicenter, open-label, Phase I study of dose escalation, PK expansion, and cohort expansion, aiming to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It includes three parts, namely dose escalation, PK expansion, and cohort expansion.
Phase Ia dose escalation is the first part (Part 1) of this study. The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D.
Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043.
Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).
A safety monitoring committee (SMC) will be established for this study. The SMC will continuously review safety during the study period and make decisions on adjustments to dose escalation, addition of new dose groups, recommended doses, and recommended exploratory cohorts. For details, please refer to the SMC Charter.
- Conditions
- Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate, Small Cell Lung Cancer, Ovarian Cancer
- Being tested
- SYS6043
- Keywords
- ovarian cancer, breast cancer, small cell lung cancer, prostate cancer
- Medical subject headings
- Neoplasms, Small Cell Lung Carcinoma, Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6043Drug
Administered by intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia dose escalation is the first part (Part 1) of this study. | Experimental | The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D (Recommended phase II dose). Receives: Drug: SYS6043 |
| Phase Ia PK expansion (Part 2). | Experimental | Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043. Receives: Drug: SYS6043 |
| Phase Ib cohort expansion (Part 3). | Experimental | Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).
Based on the obtained clinical study data and the participants' benefit/risk assessments, the SMC may consider initiating some or all of the following cohorts and may terminate enrollment for certain cohorts early based on clinical study data after initiation:
Cohort 1: Extensive-stage small cell lung cancer (ES-SCLC) after treatment failure of systemic standard of care; Cohort 2: Advanced/unresectable or metastatic HR+ HER2- breast carcinoma Cohort 3: Advanced/unresectable or metastatic castration-resistant prostate cancer (mCRPC) after treatment failure of systemic standard of care. Participants with prostate cancer whose disease is limited to metastases to bone will comprise no more than 20% of the enrolled population; Cohort 4: Advanced/unresectable or metastatic ovarian carcinoma Receives: Drug: SYS6043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a).
Assessment of the MTD and/or RP2D (recommended Phase II dose).
Measured: An average of 1 year.
Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities (DLTs) [Safety and Tolerability] of SYS6043 during the study (Phase 1a)
Number of participants with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE v5.0
Measured: An average 1 year
Secondary outcomes (7)
SYS6043 Pharmacokinetic
SYS6043 Pharmacokinetic: Peak Plasma Concentration (Cmax)
Measured: An average 1 year
SYS6043 Pharmacokinetic
SYS6043 Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)
Measured: An average 1 year
SYS6043 Pharmacokinetic
SYS6043 Pharmacokinetic: Elimination half-life (t1/2)
Measured: An average 1 year
SYS6043 Pharmacokinetic
SYS6043 Pharmacokinetic: Clearance (CL)
Measured: An average 1 year
Objective response rate (ORR)
Objective response rate (ORR). ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors is observed as best overall response.
Measured: An average 1 year
SYS6043 Immunogenicity
SYS6043 Immunogenicity: Number of participants with anti-drug-antibody (ADA).
Measured: An average 1 year
B7-H3 protein expression levels
B7-H3 protein expression levels
Measured: An average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start3 Mar 2026
- Primary completionDec 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study will employ the Bayesian optimal interval (BOIN) design. BOIN design stage: The target toxicity rate for MTD is 0.3; the sample size of the BOIN design stage is approximately 36. Dose escalation and de-escalation decisions will be made based on the occurrence of DLTs during the observation period. After the end of study, isotonic regression will be used to determine the MTD.
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424547
- Sponsor's protocol ID
- SYS6043-US-001
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diagnosis And Treatment Guidelines For Colorectal Cancer Working Group CSOCOC. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for colorectal cancer 2018 (English version). Chin J Cancer Res. 2019 Feb;31(1):117-134. doi: 10.21147/j.issn.1000-9604.2019.01.07. No abstract available.
PubMed 30996570Chengyu Yan et al., 2023.Research Progress in Immunotherapy of Esophageal Cancer. Advances in Clinical Medicine; 13(5): 8107-8115.
Ganti AKP, Loo BW, Bassetti M, Blakely C, Chiang A, D'Amico TA, D'Avella C, Dowlati A, Downey RJ, Edelman M, Florsheim C, Gold KA, Goldman JW, Grecula JC, Hann C, Iams W, Iyengar P, Kelly K, Khalil M, Koczywas M, Merritt RE, Mohindra N, Molina J, Moran C, Pokharel S, Puri S, Qin A, Rusthoven C, Sands J, Santana-Davila R, Shafique M, Waqar SN, Gregory KM, Hughes M. Small Cell Lung Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Dec;19(12):1441-1464. doi: 10.6004/jnccn.2021.0058.
PubMed 34902832
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07424547
- Acronym / sponsor ID
- SYS6043-US-001
- Conditions
- Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate, Small Cell Lung Cancer, Ovarian Cancer
- Keywords
- ovarian cancer, breast cancer, small cell lung cancer, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 20 Feb 2026 (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.
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works.
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment.
- Have safety follow-up (SFU), and long-term follow-up.
- Be followed until progression.
Detailed description
This is a multicenter, open-label, Phase I study of dose escalation, PK expansion, and cohort expansion, aiming to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It includes three parts, namely dose escalation, PK expansion, and cohort expansion.
Phase Ia dose escalation is the first part (Part 1) of this study. The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D.
Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043.
Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).
A safety monitoring committee (SMC) will be established for this study. The SMC will continuously review safety during the study period and make decisions on adjustments to dose escalation, addition of new dose groups, recommended doses, and recommended exploratory cohorts. For details, please refer to the SMC Charter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will employ the Bayesian optimal interval (BOIN) design. BOIN design stage: The target toxicity rate for MTD is 0.3; the sample size of the BOIN design stage is approximately 36. Dose escalation and de-escalation decisions will be made based on the occurrence of DLTs during the observation period. After the end of study, isotonic regression will be used to determine the MTD.
| Arm | Type | Receives |
|---|---|---|
| Phase Ia dose escalation is the first part (Part 1) of this study. | Experimental | Drug: SYS6043The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D (Recommended phase II dose). |
| Phase Ia PK expansion (Part 2). | Experimental | Drug: SYS6043Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043. |
| Phase Ib cohort expansion (Part 3). | Experimental | Drug: SYS6043Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels). Based on the obtained clinical study data and the participants' benefit/risk assessments, the SMC may consider initiating some or all of the following cohorts and may terminate enrollment for certain cohorts early based on clinical study data after initiation: Cohort 1: Extensive-stage small cell lung cancer (ES-SCLC) after treatment failure of systemic standard of care; Cohort 2: Advanced/unresectable or metastatic HR+ HER2- breast carcinoma Cohort 3: Advanced/unresectable or metastatic castration-resistant prostate cancer (mCRPC) after treatment failure of systemic standard of care. Participants with prostate cancer whose disease is limited to metastases to bone will comprise no more than 20% of the enrolled population; Cohort 4: Advanced/unresectable or metastatic ovarian carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years old (on the date of signing the ICF).
- Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.
- Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.
- Expected life expectancy of ≥ 3 months.
- ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.
Key exclusion criteria (15 listed)
- Prior B7-H3 targeted therapy.
- Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).
- Symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) or a history of severe arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment.
- Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to >470 ms.
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 |
|---|---|---|
| SYS6043Administered by intravenous injection | Drug | Phase Ia PK expansion (Part 2)., Phase Ia dose escalation is the first part (Part 1) of this study., Phase Ib cohort expansion (Part 3). |
Primary outcome
Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a).
Time frame: An average of 1 year.
Assessment of the MTD and/or RP2D (recommended Phase II dose).
Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities (DLTs) [Safety and Tolerability] of SYS6043 during the study (Phase 1a)
Time frame: An average 1 year
Number of participants with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE v5.0
7 secondary outcomes
SYS6043 Pharmacokinetic
Time frame: An average 1 year
SYS6043 Pharmacokinetic
Time frame: An average 1 year
SYS6043 Pharmacokinetic
Time frame: An average 1 year
SYS6043 Pharmacokinetic
Time frame: An average 1 year
Objective response rate (ORR)
Time frame: An average 1 year
SYS6043 Immunogenicity
Time frame: An average 1 year
B7-H3 protein expression levels
Time frame: An average 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 30996570Diagnosis And Treatment Guidelines For Colorectal Cancer Working Group CSOCOC. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for colorectal cancer 2018 (English version). Chin J Cancer Res. 2019 Feb;31(1):117-134. doi: 10.21147/j.issn.1000-9604.2019.01.07. No abstract available.
- BackgroundChengyu Yan et al., 2023.Research Progress in Immunotherapy of Esophageal Cancer. Advances in Clinical Medicine; 13(5): 8107-8115.
- Background: PubMed 34902832Ganti AKP, Loo BW, Bassetti M, Blakely C, Chiang A, D'Amico TA, D'Avella C, Dowlati A, Downey RJ, Edelman M, Florsheim C, Gold KA, Goldman JW, Grecula JC, Hann C, Iams W, Iyengar P, Kelly K, Khalil M, Koczywas M, Merritt RE, Mohindra N, Molina J, Moran C, Pokharel S, Puri S, Qin A, Rusthoven C, Sands J, Santana-Davila R, Shafique M, Waqar SN, Gregory KM, Hughes M. Small Cell Lung Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Dec;19(12):1441-1464. doi: 10.6004/jnccn.2021.0058.
- 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.
5 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 SYS6043 in people with Cancer and Solid Tumor Cancer, run by Conjupro Biotherapeutics, Inc. at 5 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Clinical Operations (609-356-0210, clinicaltrials.gov@cspcus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a). (time frame: An average of 1 year.). 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 NCT07424547, which also lists 3 linked publications.
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 7 Apr 2026.