Lung Cancer (NSCLC)Phase 1NCT07181473
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing TJ101 in people with Lung Cancer (NSCLC) and Prostate Cancer, run by Phrontline Biopharma at 7 sites in 2 countries.
Trial summary
The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Prostate Cancer, Esophageal Cancer
- What is being tested?
- TJ101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Aug 2025to 15 Sep 2027
- 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
- Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
- Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
- Men or women ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.
- Life expectancy of ≥ 12 weeks;
- Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing.
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- Hepatic function: AST and ALT ≤ 2.5 x upper limit of normal (ULN); if liver metastases, then ≤ 5 x ULN. Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome.
- Albumin ≥3g/dL.
- Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; APTT≤1.5×ULN.
- Renal function: Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft and Gault equation) (Cockcroft DW, 1976)
- Hematopoietic function (without infusion of blood product, use of G-CSF or other treatments to correct blood count within 14 days): Hemoglobin (HGB) ≥ 90 g/L; Platelet count (PLT) ≥ 100×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L;
- Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female patients of childbearing potential must agree to use effective methods of contraception from the time of informed consent, throughout the study and for 6 months after the last dose of the investigational product.
- Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
Who cannot join
- Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal);
- Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;
- Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;
- Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;
- Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ101; Current participation in other interventional clinical studies (participation in survival follow-up is allowed);
- Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V5.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing loss) that will not increase the safety risk may be eligible at the discretion of the Investigator.
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- Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis can't be ruled out by imaging at screening.
- Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator.
- Uncontrolled or significant cardiovascular disease, including:
- Prolongation of the average Corrected QT interval (QTc, Fridericia's correction formula used) (> 470 ms regardless of sex).
- Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class II-IV of New York Heart Association [NYHA]) or acute myocardial infarction within preceding 6 months.
- History of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Uncontrolled hypertension defined as systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg while receiving more than one kind of antihypertensive drug.
- For patients with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, only the following patients may be eligible as evaluated by the sponsor and investigator:
- Patients with active hepatitis B: HBV DNA ≤500 IU/mL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), who have controlled infection (HCV RNA≤ULN by polymerase chain reaction [PCR] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician.
- Known HIV infection;
- Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease);
- Active central nervous system (CNS) metastases or meningeal metastases. Subjects may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks (ie, imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg/day (or equivalent dose).
- Other malignancies within 3 years prior to initiation of TJ101 treatment (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence) will confound safety/efficacy of this trial or pose a risk to the participants;
- Female patients who are lactating or breastfeeding.
- The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
China4 sites, 4 recruiting
- Not yet recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Hongming Pan, +86 571 8692 1744, shono@sina.cn
Hongming Pan
- Recruiting
Shanghai East Hospital
Shanghai
Caicun Zhou, +86 021-038804518, caicunzhoudr@163.com
Caicun Zhou
- Not yet recruiting
Union Hospital of Tongji Medical College
Wuhan, Hubei
Kunyu Yang, +86 027-85726754, Yangky71@aliyun.com
Kunyu Yang
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yanqiu Zhao, +86 0371-65587161, 13938252350@163.com
Yanqiu Zhao
United States3 sites, 3 recruiting
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Julio Peguero, Md, 855-827-9525, jpeguero@oncologyconsultants.com
- Recruiting
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
Misty Moore, 615-524-4025
- Recruiting
Florida Cancer Specialists & Research Institute
Orlando, Florida, 32827
Elizabeth Gilmore, 904-380-2410
About this study
Official title: A Phase I, First in Human (FIH), Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Preliminary Efficacy and Immunogenicity of TJ101 for Injection in Patients With Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors.
The main objectives of this study are :
Read more
- To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101
- to show preliminary antitumor activity in patients with advanced solid tumors
Participants will:
- Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose.
- Undergo regular tumor imaging to assess response.
- Provide blood samples for pharmacokinetics (PK) and biomarker analysis.
- Be monitored for side effects and overall tolerability.
This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
Read the detailed description
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of TJ101, a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3, in patients with advanced or metastatic solid tumors.
Study Objectives Phase Ia (Dose Escalation)
- Primary: Assess safety/tolerability; determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose(s) for expansion (RDEs).
- Secondary: Characterize PK profile, assess preliminary anti-tumor activity, and evaluate immunogenicity.
Phase Ib (Dose Expansion)
- Primary: Further assess safety and preliminary anti-tumor activity of TJ101 at the selected RDEs.
- Secondary: Further characterize PK profile and immunogenicity.
Study Design
- Part 1: Dose Escalation (Phase Ia)
- Up to 72 patients with advanced/metastatic solid tumors.
- Six planned dose cohorts: IV every 3 weeks (Q3W).
- Accelerated titration for first cohort; 3+3 design for subsequent cohorts.
- Backfill cohorts (6-12 patients each) may be added at promising dose levels to refine safety, PK, and efficacy data.
- DLT evaluation window: 21 days after first infusion (Cycle 1).
- Safety Monitoring Committee (SMC) reviews all data to guide escalation, backfill, and RDE selection.
Part 2: Dose Expansion (Phase Ib)
- 40-180 patients, across tumor-specific cohorts
- Patients randomized to 2-3 RDEs of TJ101.
- 20-30 subjects per tumor type/dose level.
- Expansion will refine safety/PK and assess anti-tumor activity in biomarker-selected subgroups.
- Dosing: IV infusion on Day 1 of each 21-day cycle; continued until progression, unacceptable toxicity, withdrawal, or investigator decision.
Study Procedures \& Monitoring
- Screening: within 28 days prior to first dose.
- Safety Monitoring: continuous AE collection, labs, vitals, ECOG, ECGs, ophthalmologic exams, skin checks.
- Efficacy Assessments: imaging at baseline, then every 6 weeks (first 24 weeks), every 9 weeks thereafter, and every 12 weeks from year 2 until progression or new therapy.
- PK/Immunogenicity Sampling: intensive during Cycles 1 and 3; serial sampling in later cycles.
- Follow-up:
- 30-day safety follow-up after last dose.
- Survival follow-up every 3 months until death or study termination.
Enrollment \& Duration
- Estimated enrollment: up to 252 patients.
- Study duration: ~ 2-3 years.
- Being tested
- TJ101
- Keywords
- TJ101, EGFR/B7-H3, phase 1, Solid Tumors
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ101Drug
TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TJ101 | Experimental | TJ101 will be infused intravenously once every 3 weeks. Participants will receive TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. Receives: Drug: TJ101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-limiting toxicities
Measuring the number of patients with Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes:
Hematological toxicities:
Grade 4 neutrophil count decreased lasting >7 days; Grade ≥3 febrile neutropenia; Grade ≥3 platelet count decreased with clinically significant hemorrhage; Grade 4 anaemia;
Non-Hematological toxicities:
Death; Hy's law cases; Grade ≥3 non-hematological toxicities.
Measured: 21 Days
Number of participants with Serious Adverse Events (SAEs)
Measuring the number of patients with Serious Adverse Events (SAEs)
Measured: 2 years
Number of participants with treatment-emergent adverse events (TEAEs)
Measuring the number of patients with AEs that occur after first study dose till 30 days after the last dose
Measured: 2 years
Number of participants with treatment-related adverse events (TRAEs)
Measuring the number of patients with treatment-related TEAEs
Measured: 2 years
Secondary outcomes (16)
Objective response rate (ORR)
Measuring the proportion of patients with complete or partial response according to RECIST 1.1 during the study
Measured: 2 years
Disease control rate (DCR)
Measuring the proportion of patients with complete response, partial response or stable disease according to RECIST 1.1 during the study
Measured: 2 years
Duration of response (DoR)
Measuring the time from the first assessment of CR or PR until the date of the first occurrence of PD or death, whichever occurs first.
Measured: 2 years
Progression-free survival (PFS)
Measuring the time from initiation of study treatment to the occurrence of PD or death, whichever occurs first.
Measured: 2 years
Overall survival (OS)
Measuring the time from initiation of study treatment to death
Measured: 2 years
Maximum observed concentration (Cmax)
Measuring maximum drug concentration in blood after study treatment
Measured: 1 year
Time to Cmax (Tmax)
Measuring time to reach maximum drug concentration in blood after study treatment
Measured: 1 year
Area under the concentration versus time curve (AUC)
Measuring area under the drug concentration versus time curve
Measured: 1 year
half-life time (t1/2)
Measuring the time for the drug concentration to reach half of its value
Measured: 1 year
Clearance (CL)
Measuring the apparent volume of plasma completely cleared of drug per unit of time
Measured: 1 year
Volume of distribution
Measuring the distribution of drugs in the body as relative to the measured concentration.
Measured: 1 year
Elimination rate constant (λz)
Measuring the fraction of drug eliminated per unit of time
Measured: 1 year
Mean residence time (MRT)
Measuring the average duration that the study drug remains in the body
Measured: 1 year
Proportion of participants with anti-drug antibodies (ADA)
Measuring the proportion of participants test positive for ADA
Measured: 1 year
Proportion of participants with neutralizing antibodies (NAb)
Measuring the proportion of participants test positive for NAb
Measured: 1 year
Titer of anti-drug antibodies (ADA)
Measuring the level of ADA. Titer is defined as the reciprocal of the highest dilution of the sample that yields a positive result.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start25 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phrontline Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181473
- Sponsor's protocol ID
- TJ101-I-001
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First in Human (FIH), Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Preliminary Efficacy and Immunogenicity of TJ101 for Injection in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07181473
- Acronym / sponsor ID
- TJ101-I-001
- Keywords
- TJ101, EGFR/B7-H3, phase 1, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Phrontline BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 18 Sep 2025 (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 evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors.
The main objectives of this study are :
- To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101
- to show preliminary antitumor activity in patients with advanced solid tumors
Participants will:
- Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose.
- Undergo regular tumor imaging to assess response.
- Provide blood samples for pharmacokinetics (PK) and biomarker analysis.
- Be monitored for side effects and overall tolerability.
This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
Detailed description
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of TJ101, a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3, in patients with advanced or metastatic solid tumors.
Study Objectives Phase Ia (Dose Escalation)
- Primary: Assess safety/tolerability; determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose(s) for expansion (RDEs).
- Secondary: Characterize PK profile, assess preliminary anti-tumor activity, and evaluate immunogenicity.
Phase Ib (Dose Expansion)
- Primary: Further assess safety and preliminary anti-tumor activity of TJ101 at the selected RDEs.
- Secondary: Further characterize PK profile and immunogenicity.
Study Design
- Part 1: Dose Escalation (Phase Ia)
- Up to 72 patients with advanced/metastatic solid tumors.
- Six planned dose cohorts: IV every 3 weeks (Q3W).
- Accelerated titration for first cohort; 3+3 design for subsequent cohorts.
- Backfill cohorts (6-12 patients each) may be added at promising dose levels to refine safety, PK, and efficacy data.
- DLT evaluation window: 21 days after first infusion (Cycle 1).
- Safety Monitoring Committee (SMC) reviews all data to guide escalation, backfill, and RDE selection.
Part 2: Dose Expansion (Phase Ib)
- 40-180 patients, across tumor-specific cohorts
- Patients randomized to 2-3 RDEs of TJ101.
- 20-30 subjects per tumor type/dose level.
- Expansion will refine safety/PK and assess anti-tumor activity in biomarker-selected subgroups.
- Dosing: IV infusion on Day 1 of each 21-day cycle; continued until progression, unacceptable toxicity, withdrawal, or investigator decision.
Study Procedures \& Monitoring
- Screening: within 28 days prior to first dose.
- Safety Monitoring: continuous AE collection, labs, vitals, ECOG, ECGs, ophthalmologic exams, skin checks.
- Efficacy Assessments: imaging at baseline, then every 6 weeks (first 24 weeks), every 9 weeks thereafter, and every 12 weeks from year 2 until progression or new therapy.
- PK/Immunogenicity Sampling: intensive during Cycles 1 and 3; serial sampling in later cycles.
- Follow-up:
- 30-day safety follow-up after last dose.
- Survival follow-up every 3 months until death or study termination.
Enrollment \& Duration
- Estimated enrollment: up to 252 patients.
- Study duration: ~ 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ101 | Experimental | Drug: TJ101TJ101 will be infused intravenously once every 3 weeks. Participants will receive TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
- Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
- Men or women ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.
- Life expectancy of ≥ 12 weeks;
Key exclusion criteria (21 listed)
- Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal);
- Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;
- Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;
- Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;
- Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ101; Current participation in other interventional clinical studies (participation in survival follow-up is allowed);
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 |
|---|---|---|
| TJ101TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor. | Drug | TJ101 |
Primary outcome
Number of participants with Dose-limiting toxicities
Time frame: 21 Days
Measuring the number of patients with Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: Grade 4 neutrophil count decreased lasting >7 days; Grade ≥3 febrile neutropenia; Grade ≥3 platelet count decreased with clinically significant hemorrhage; Grade 4 anaemia; Non-Hematological toxicities: Death; Hy's law cases; Grade ≥3 non-hematological toxicities.
Number of participants with Serious Adverse Events (SAEs)
Time frame: 2 years
Measuring the number of patients with Serious Adverse Events (SAEs)
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: 2 years
Measuring the number of patients with AEs that occur after first study dose till 30 days after the last dose
Number of participants with treatment-related adverse events (TRAEs)
Time frame: 2 years
Measuring the number of patients with treatment-related TEAEs
16 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DoR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Maximum observed concentration (Cmax)
Time frame: 1 year
Time to Cmax (Tmax)
Time frame: 1 year
Area under the concentration versus time curve (AUC)
Time frame: 1 year
half-life time (t1/2)
Time frame: 1 year
Clearance (CL)
Time frame: 1 year
Volume of distribution
Time frame: 1 year
Elimination rate constant (λz)
Time frame: 1 year
Mean residence time (MRT)
Time frame: 1 year
Proportion of participants with anti-drug antibodies (ADA)
Time frame: 1 year
Proportion of participants with neutralizing antibodies (NAb)
Time frame: 1 year
Titer of anti-drug antibodies (ADA)
Time frame: 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 12 Jan 2026.
- 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ101 in people with Lung Cancer (NSCLC) and Prostate Cancer, run by Phrontline Biopharma at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, 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 Martin S Olivo, MD (551-427-2578, martin.olivo@phrontlinebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose-limiting toxicities (time frame: 21 Days). The study lists 4 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 12 Jan 2026.