Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or LymphomaPhase 1/2NCT05842785
TSN222 in Subjects With Advanced Solid Tumors or Lymphomas
A Phase 1/2 study testing Phase I dose escalation, Phase II-HNSCC and Phase II-Advanced melanoma in people with Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma, run by Tyligand Bioscience (Shanghai) Limited at 1 site in China.
Trial summary
The study is a first-in-human [FIH], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma
- What is being tested?
- Phase I dose escalation, Phase II-HNSCC and Phase II-Advanced melanoma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to 1 Jun 2026
- Phase
- Phase 1/2
- 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
- Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
- The subject fully understands the requirements of the study and voluntarily signs the ICF.
- At least 18 years of age at the time of informed consent.
- Life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Willing to provide tumor tissues and accept tumor biopsies during study.
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- At least one measurable tumor lesion per RECIST v1.1 or Lugano 2014 response criteria (only applicable for phase 2); note: the measurable lesions should be non-injected and non-biopsied during study.
- Subjects must meet the following criteria for each of the respective parts of the study
- Phase 1 part:
- Has a pathologically documented unresectable locally advanced or metastatic solid tumor or lymphoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Phase 2 part:
- Cohort 1: Has pathologically confirmed diagnosis of unresectable locally advanced or metastatic HNSCC that is considered incurable by local therapies, and is refractory to or intolerable with at least one systemic treatment in the advanced setting.
- Cohort 2: Has pathologically confirmed diagnosis of unresectable locally advanced or metastatic melanoma that is refractory to or intolerable with at least prior two systemic treatments in the advanced setting for BRAF mutant subjects, or at least one systemic treatment in the advanced setting for BRAF non-mutant subjects.
- Cohort 3: Has pathologically confirmed diagnosis of unresectable locally advanced or metastatic other solid tumors or lymphomas that is refractory to or intolerable with at least one systemic treatment in the advanced setting, or for which no standard treatment is available.
- 9. Adequate bone marrow function: 10. Adequate renal function: estimated creatinine clearance ≥ 50 mL/min as calculated using Cockcroft-Gault formula.
- 11. Adequate liver function: 12. Blood albumin ≥ 30g/L. 13. Adequate coagulation function: 14. Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception during the treatment period and for at least 6 months after the last dose of TNS222. Contraception methods should be consistent with local regulations. Refer to Appendix 6 for details and definitions of WOCBP, postmenopausal females and contraception guidance.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS directed therapy are eligible for study entry.
- Prior history of active malignant disease other than that being treated in this study. Exceptions: malignancies that were treated curatively and have not recurred within the past 5 years (i.e., completely resected basal cell carcinoma and squamous cell carcinoma of the skin; and completely resected carcinoma in situ of any type) (only applicable to phase 2 part).
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia and grade 2 peripheral neuropathy.
- Prior systemic anti-cancer treatment (chemotherapy, biologic therapy, or targeted therapy or herbal medicine) within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug; or prior systemic anti-tumor immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to the first dose of study drug.
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- Has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of study drug.
- Major surgery within 4 weeks prior to first dose of study drug.
- Severe infection within 4 weeks prior to the first dose of study drug, active infection requiring oral or intravenous antibiotics within 2 weeks prior to the first dose of study drug.
- Active viral hepatitis.
- History of human immunodeficiency virus (HIV) infection.
- Known interstitial lung disease history, or current active pneumonitis, radiation pneumonitis requiring hormonal therapy, or uncontrolled lung disease.
- Symptomatic uncontrolled effusion in body cavities (e.g., pleural effusion, ascites and pericardial effusion).
- History of significant bleeding event (> 30ml) within 3 months before the first dosing or hemoptysis (> 2.5 mL of bright red blood or at least 0.5 teaspoon per episode) within 4 weeks before the first dosing；
- Severe cardiovascular disease within 6 months of the first dose including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association (NYHA) class III or IV heart failure or uncontrolled arrhythmia.
- Uncontrolled hypertension (systolic pressure >150mmHg or diastolic pressure > 90mmHg).
- Has the average corrected QT interval by Fridericia's formula (QTcF) prolongation to > 480 millisecond (ms) based on 12-lead electrocardiograph (ECG) in triplicate, or with a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives).
- Severe gastrointestinal disease, including but not limited to:
- Peptic ulcer disease in the past 3 months prior to the first dosing.
- Clinically significant gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months prior to the first dosing without evidence of resolution documented by endoscopy or colonoscopy.
- Active colitis requiring ongoing treatment within 4 weeks prior to the first dosing, including infectious colitis, radiation colitis and ischemic colitis.
- History of ulcerative colitis or Crohn's disease.
- Active autoimmune diseases or history of autoimmune diseases that may relapse, or high-risk conditions (e.g., prior allogeneic hematopoietic stem cell transplantation or organ transplantation that requires immunosuppression), with the following exceptions: controlled type 1 diabetes, autoimmune hypothyroidism (provided it is managed with hormone replacement therapy only).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of investigational product, with the following exceptions:
- Topical, ocular, intra articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
- Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen).
- Receipt of any live vaccines within 4 weeks prior to first dose of study drug.
- Females who are pregnant or nursing.
- Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan Cancer Hospital
Shanghai, Shanghai Municipality, 200063
Jian Zhang
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of TSN222 in Subjects With Advanced Solid Tumors or Lymphoma
The study is a first-in-human [FIH], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component.
Read the detailed description
Phase 1 Part:
Using the standard 3+3 design for dose escalation, the Phase 1 Part will evaluate the prespecified 6 sequential dose levels of 100 microgram (μg), 200 μg, 400 μg, 800 μg, 1600 μg, and 3200 μg of TSN222 as a single agent in subjects with advanced solid tumors or lymphomas.
The eligible subjects will receive TSN222 via i.t. injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. The dose-limiting toxicity (DLT) observation period will be defined as the first 28 days after the first dose (i.e. the first cycle). Based on the standard "3+3" design, cohorts of 3 to 6 subjects each will be sequentially assigned to the predefined dose levels. Dose escalation will continue until up to the highest planned dose or the MTD or RP2D is determined.
Phase 2 Part:
Phase 2 part will evaluate the efficacy and safety of TSN222 as monotherapy at the preliminary RP2D(s) in 3 cohorts bellow:
Cohort 1: advanced squamous cell carcinoma of head and neck (HNSCC). Cohort 2: advanced melanoma. Cohort 3: advanced other types of solid tumors or lymphomas.
- Conditions
- Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma
- Being tested
- Phase I dose escalation, Phase II-HNSCC, Phase II-Advanced melanoma, Phase II-solid tumors or lymphomas
- Medical subject headings
- Neoplasm Metastasis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I dose escalationDrug
The eligible subjects will receive TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Phase II-HNSCCDrug
The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Phase II-Advanced melanomaDrug
The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Phase II-solid tumors or lymphomasDrug
The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose escalation | Experimental | 100 microgram (μg), 200 μg, 400 μg, 800 μg, 1600 μg, and 3200 μg of TSN222 as a single agent in subjects with advanced solid tumors or lymphomas. Receives: Drug: Phase I dose escalation |
| Phase II-HNSCC | Experimental | Patients with advanced squamous cell carcinoma of head and neck (HNSCC). Receives: Drug: Phase II-HNSCC |
| Phase II-Advanced melanoma | Experimental | patients with the advanced melanoma. Receives: Drug: Phase II-Advanced melanoma |
| Phase II-solid tumors or lymphomas. | Experimental | patients with advanced other types of solid tumors or lymphomas. Receives: Drug: Phase II-solid tumors or lymphomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I-Safety
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
AEs as characterized by nature, frequency, and severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Secondary safety endpoint. The abnormal findings of vital sign, physical examination, laboratory measurements, ECG and ECHO/ MUGA parameters.
Measured: 28 days
Phase I and phase II-Safety
AEs as characterized by nature, frequency, and severity according to NCI CTCAE version 5.0.
Measured: Any AEs (including SAEs) that occurs after first dose through 28 days after receiving the last dose of TSN222
Phase II
ORR based on investigator assessment using RECIST v 1.1 for solid tumor or Lugano 2014 response criteria for lymphomas.
Measured: baseline and throughout the study
Secondary outcomes (2)
Phase I/II: PK profile
Plasma concentrations and PK parameters of TSN222 and its metabolites including but not limited to area under the plasma concentration-time curve (AUC), maximum concentrations (Cmax), trough concentrations (Ctrough).
Measured: From Cycle 1 to the first day of Cycle 2
Phase I/II: To evaluate the preliminary anti-tumor activity of TSN222
Based on investigators assessment:
Overall response rate (ORR). Duration of response (DOR). Time to response (TTR). Disease control rate (DCR). Progression free survival (PFS).
Measured: Durting the period of patient treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start26 Jul 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Firstly conduct the phase I and find the RP2D. Once we have the RP2D, we will conduct the phase II study.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyligand Bioscience (Shanghai) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Principal investigator, Fudan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842785
- Sponsor's protocol ID
- TSN222-101CH
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of TSN222 in Subjects With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT05842785
- Acronym / sponsor ID
- TSN222-101CH
- Conditions
- Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Tyligand Bioscience (Shanghai) LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 May 2023 (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 study is a first-in-human [FIH], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component.
Detailed description
Phase 1 Part:
Using the standard 3+3 design for dose escalation, the Phase 1 Part will evaluate the prespecified 6 sequential dose levels of 100 microgram (μg), 200 μg, 400 μg, 800 μg, 1600 μg, and 3200 μg of TSN222 as a single agent in subjects with advanced solid tumors or lymphomas.
The eligible subjects will receive TSN222 via i.t. injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. The dose-limiting toxicity (DLT) observation period will be defined as the first 28 days after the first dose (i.e. the first cycle). Based on the standard "3+3" design, cohorts of 3 to 6 subjects each will be sequentially assigned to the predefined dose levels. Dose escalation will continue until up to the highest planned dose or the MTD or RP2D is determined.
Phase 2 Part:
Phase 2 part will evaluate the efficacy and safety of TSN222 as monotherapy at the preliminary RP2D(s) in 3 cohorts bellow:
Cohort 1: advanced squamous cell carcinoma of head and neck (HNSCC). Cohort 2: advanced melanoma. Cohort 3: advanced other types of solid tumors or lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Firstly conduct the phase I and find the RP2D. Once we have the RP2D, we will conduct the phase II study.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose escalation | Experimental | Drug: Phase I dose escalation100 microgram (μg), 200 μg, 400 μg, 800 μg, 1600 μg, and 3200 μg of TSN222 as a single agent in subjects with advanced solid tumors or lymphomas. |
| Phase II-HNSCC | Experimental | Drug: Phase II-HNSCCPatients with advanced squamous cell carcinoma of head and neck (HNSCC). |
| Phase II-Advanced melanoma | Experimental | Drug: Phase II-Advanced melanomapatients with the advanced melanoma. |
| Phase II-solid tumors or lymphomas. | Experimental | Drug: Phase II-solid tumors or lymphomaspatients with advanced other types of solid tumors or lymphomas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
- The subject fully understands the requirements of the study and voluntarily signs the ICF.
- At least 18 years of age at the time of informed consent.
- Life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (29 listed)
- Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS directed therapy are eligible for study entry.
- Prior history of active malignant disease other than that being treated in this study. Exceptions: malignancies that were treated curatively and have not recurred within the past 5 years (i.e., completely resected basal cell carcinoma and squamous cell carcinoma of the skin; and completely resected carcinoma in situ of any type) (only applicable to phase 2 part).
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia and grade 2 peripheral neuropathy.
- Prior systemic anti-cancer treatment (chemotherapy, biologic therapy, or targeted therapy or herbal medicine) within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug; or prior systemic anti-tumor immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| Phase I dose escalationThe eligible subjects will receive TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | Drug | Phase I Dose escalation |
| Phase II-HNSCCThe eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | Drug | Phase II-HNSCC |
| Phase II-Advanced melanomaThe eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | Drug | Phase II-Advanced melanoma |
| Phase II-solid tumors or lymphomasThe eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | Drug | Phase II-solid tumors or lymphomas. |
Primary outcome
Phase I-Safety
Time frame: 28 days
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. AEs as characterized by nature, frequency, and severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Secondary safety endpoint. The abnormal findings of vital sign, physical examination, laboratory measurements, ECG and ECHO/ MUGA parameters.
Phase I and phase II-Safety
Time frame: Any AEs (including SAEs) that occurs after first dose through 28 days after receiving the last dose of TSN222
AEs as characterized by nature, frequency, and severity according to NCI CTCAE version 5.0.
Phase II
Time frame: baseline and throughout the study
ORR based on investigator assessment using RECIST v 1.1 for solid tumor or Lugano 2014 response criteria for lymphomas.
2 secondary outcomes
Phase I/II: PK profile
Time frame: From Cycle 1 to the first day of Cycle 2
Phase I/II: To evaluate the preliminary anti-tumor activity of TSN222
Time frame: Durting the period of patient treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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.
Jian Zhang principal investigator
Fudan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I dose escalation, Phase II-HNSCC and Phase II-Advanced melanoma in people with Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma, run by Tyligand Bioscience (Shanghai) Limited at 1 site in China.
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 16 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tyligand Clinical Trial Info (8621-50720081, clinical_trial@tyligand.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I-Safety (time frame: 28 days). 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?
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 2024.