Advanced Solid Tumor (Phase 1)Phase 1NCT07434609
Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
A Phase 1 study testing T320 for Injection in people with Advanced Solid Tumor (Phase 1), run by Nanolattix Biotechnology Co., Ltd..
Trial summary
This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor (Phase 1)
- What is being tested?
- T320 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2027to 1 Dec 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
- Voluntary to participate in the clinical study, sign a written informed consent form, and able to comply with clinical visits and study-related procedures.
- Age ≥18 years old upon signing the informed consent form.
- Have histologically and/or cytologically confirmed unresectable advanced solid tumour who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.
- Escalation module: preferred tumour types include cervix, ovary, endometrium, pancreatic, bladder, prostate, esophageal cancer, HNSCC, triple-negative breast cancer (TNBC), cholangiocarcinoma, and NSCLC. Backfill module: patients with cervix cancer, pancreatic cancer, HNSCC, NSCLC, ovarian and endometrial cancer.
- ECOG performance score of 0 ~ 2.
- Life expectancy ≥ 3 months.
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- At least one measurable lesion per RECIST v1.1.
- Adequate organ function defined as following: a) Hematological status: neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 90×109/L, and hemoglobin (HGB) > 9.0 g/dL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days before the evaluation). b) Coagulation function: international normalized ratio (INR) ≤1.2 (without anticoagulant therapy) and activated partial prothrombin time (APTT) ≤1.25×ULN. c) Liver function: total bilirubin (TBIL) ≤ 1.5×ULN or ≤ 3×ULN in case of Gilbert's syndrome; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT and AST ≤ 5×ULN. d) Renal function: creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min. e) Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; QTcF≤470 ms by Fridericia formula.
- Eligible patients with fertility (male and female) must agree to use reliable contraceptive methods with their partners during the trial period and at least 3 months after the last IP administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first investigational drug administration.
- Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Who cannot join
- Any anti-cancer therapy including chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment.
- Known past or current coagulation defects leading to an increased risk of bleeding or any known bleeding diathesis.
- History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
- Known to be allergic to T320 for injection or any of its excipients, or patients with allergic constitution.
- Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
- Known history of non-infectious pneumonitis (NIP)/interstitial lung disease (ILD) requiring systemic steroids, active NIP/ILD, or other severe lung disease.
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- Presence of grade ≥ 2 peripheral neuropathy.
- Ongoing acute or chronic inflammatory skin disease.
- Presence of ocular surface disease (i.e., confluent superficial keratitis, cornea epithelial defect, corneal ulcer, stromal opacity, etc) or history of conjunctivitis.
- Presence of acute bacterial, viral or fungal infections.
- Untreated, unstable or uncontrolled central nervous system (CNS) metastases, except for: a) No evidence of cerebral edema and no systemic steroids or anticonvulsants requirement at screening and follow-up MRI scan performed within 28 days prior to the first dose of the IMP showing no progression of treated lesion(s) and no new lesion(s) appearing. b) Untreated asymptomatic brain metastasis and no need of local/systematic therapy currently.
- Any prior therapy with a conjugated or unconjugated auristatin derivative.
- Patient requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 (Table 3) within 2 weeks prior to the first dose and during the study treatment.
- Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation, or plan to receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation during the study period.
- History of or currently central nervous system (CNS) lymphoma or other central nervous system diseases.
- Known to have any active infection of human immunodeficiency virus (HIV),hepatitis B virus (HBV) or hepatitis C virus (HCV). However, patients with the following conditions can be included in this study: a) Human immunodeficiency virus antibody (HIV-Ab) is negative, or HIVAb is positive but nucleic acid test shows an undetectable viral load (viral suppression is defined as having less than 200 copies of HIV per milliliter of blood) i.e., well-controlled HIV patients can be enrolled. b) Hepatitis B surface antigen (HBsAg) is negative; if HBsAg or HBcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) < 1000 cps/mL. c) Hepatitis C virus antibody (HCV-Ab) is negative.
- Toxicity except for alopecia and fatigue caused by previous anti-tumour therapy has not been alleviated to grade 1 or below (CTCAE v5.0).
- History of other malignant tumor within 2 years before enrollment, except for skin basal cell carcinoma, skin squamous cell carcinoma, and carcinoma in situ that have undergone possible curative treatment and have not recurred within 5 years after the start of treatment.
- Have received any other investigational drug product within 28 days or 5 halflives of the previous investigational drug (if required) before screening.
- Have used live attenuated vaccines within 4 weeks before the first administration of dexamethasone or are expected to use live attenuated vaccines during the study period.
- Have used systemic immunosuppressive drugs within 4 weeks before the first administration, including but not limited to radiotherapy immunoconjugates, antibody-drug conjugates, immune/cytokines, monoclonal antibodies, etc. Except for continuous corticosteroids at a dose of <10 mg prednisone/day or equivalent.
- History of autoimmune diseases, including but not limited to myocarditis, pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis or glomerulonephritis.
- Have undergone major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before the first administration of IP, or need to undergo elective surgery during the trial period.
- Have serious unhealable wound/ulcer/fracture within 4 weeks before the first administration of investigational drug.
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to:1) Serious heart rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, degree II-III atrioventricular block, etc. 2) Thromboembolic events requiring therapeutic anticoagulation, or subjects with venous filters. 3) Patients with Class III~IV cardiac insufficiency according to the New York Heart Association (NYHA) criteria. 4) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months before the first administration.
- 5) Clinically uncontrollable hypertension (blood pressure cannot be controlled at systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg after standard antihypertensive treatment). 6) Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or use of any concomitant drug that are known to or may prolong the QT interval.
- Substance use disorder that may interfere with the participant's involvement in the study or evaluation of the study result, as determined by the investigator.
- Patient with mental disorders that would affect participation in the trial or poor compliance.
- Women who are pregnant or breastfeeding.
- Patient who cannot tolerate venous blood sampling.
- The investigator believes that the subject has a history of other serious systemic diseases or is not suitable for participating in this clinical study for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumor
This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. The trial process for each subject in both escalation and backfill module includes a screening period (28 days before the first T320 administration), a treatment period (from the first T320 administration to the end of reatment), a safety follow-up period (28 days after EOT/early withdrawal) and a progression follow-up period (every 12 weeks from safety follow-up visit). Patients will receive T320 administration once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.
- Conditions
- Advanced Solid Tumor (Phase 1)
- Being tested
- T320 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T320 for InjectionBiological
T320 for Injection
| Study group | Role | What they receive |
|---|---|---|
| T320 for Injection | Experimental | Not described Receives: Biological: T320 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: Q2W: Up to 28 days
Adverse event (AE) assessed by CTCAE v5.0
Measured: The period of AE collection starts after the subject receives the T320, until 28+7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first).
Serious adverse events (SAEs)
Measured: From the signing of the informed consent to 28±7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first), through study completion, an average of 1 year.
maximum tolerated dose (MTD)
Measured: Q2W: Up to 28 days
recommended Phase 2 dose (RP2D)
RP2D as administered once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.
Measured: The RP2D will be finally selected by pooling and evaluating all available efficacy, PK, safety and tolerability data in dose escalation and backfill module, through study completion, an average of 1 year.
heart rate
Measured: through study completion, an average of 1 year
electrocardiogram (ECG) QT Interval
Measured: through study completion, an average of 1 year
Secondary outcomes (17)
Best overall response (BOR)
Measured: through study completion, an average of 1 year
Overall response rate (ORR)
Measured: through study completion, an average of 1 year
Disease control rate (DCR)
Measured: through study completion, an average of 1 year
Progression-free survival (PFS)
Measured: through study completion, an average of 1 year
Maximum observed serum concentration (Cmax)
Measured: through study completion, an average of 1 year
Anti-drug antibody (ADA)
Measured: through study completion, an average of 1 year
Time to reach Cmax (Tmax)
Measured: through study completion, an average of 1 year
Area under concentration-time profiles from zero to last timepoint of measurable concentration (AUClast)
Measured: through study completion, an average of 1 year
Area under concentration-time profiles during a dose interval (AUCtau)
Measured: through study completion, an average of 1 year
Terminal half-life (T1/2)
Measured: through study completion, an average of 1 year
Steady state maximum concentration (Cmax, ss)
Measured: through study completion, an average of 1 year
Steady state minimum concentration (Cmin, ss)
Measured: through study completion, an average of 1 year
Clearance at steady state (CLss)
Measured: through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
Measured: through study completion, an average of 1 year
Ratio of AUC (Rac,AUC)
Measured: through study completion, an average of 1 year
Ratio of Cmax (Rac,Cmax)
Measured: through study completion, an average of 1 year
Degree of fluctuation (DF)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Dec 2027 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor (Phase 1)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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanolattix Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434609
- Sponsor's protocol ID
- T320-001US
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT07434609
- Acronym / sponsor ID
- T320-001US
- Conditions
- Advanced Solid Tumor (Phase 1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanolattix Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 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.
This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. The trial process for each subject in both escalation and backfill module includes a screening period (28 days before the first T320 administration), a treatment period (from the first T320 administration to the end of reatment), a safety follow-up period (28 days after EOT/early withdrawal) and a progression follow-up period (every 12 weeks from safety follow-up visit). Patients will receive T320 administration once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T320 for Injection | Experimental | Biological: T320 for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary to participate in the clinical study, sign a written informed consent form, and able to comply with clinical visits and study-related procedures.
- Age ≥18 years old upon signing the informed consent form.
- Have histologically and/or cytologically confirmed unresectable advanced solid tumour who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.
- Escalation module: preferred tumour types include cervix, ovary, endometrium, pancreatic, bladder, prostate, esophageal cancer, HNSCC, triple-negative breast cancer (TNBC), cholangiocarcinoma, and NSCLC. Backfill module: patients with cervix cancer, pancreatic cancer, HNSCC, NSCLC, ovarian and endometrial cancer.
- ECOG performance score of 0 ~ 2.
Key exclusion criteria (31 listed)
- Any anti-cancer therapy including chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment.
- Known past or current coagulation defects leading to an increased risk of bleeding or any known bleeding diathesis.
- History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
- Known to be allergic to T320 for injection or any of its excipients, or patients with allergic constitution.
- Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
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 |
|---|---|---|
| T320 for InjectionT320 for Injection | Biological | T320 for Injection |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Q2W: Up to 28 days
Adverse event (AE) assessed by CTCAE v5.0
Time frame: The period of AE collection starts after the subject receives the T320, until 28+7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first).
Serious adverse events (SAEs)
Time frame: From the signing of the informed consent to 28±7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first), through study completion, an average of 1 year.
maximum tolerated dose (MTD)
Time frame: Q2W: Up to 28 days
recommended Phase 2 dose (RP2D)
Time frame: The RP2D will be finally selected by pooling and evaluating all available efficacy, PK, safety and tolerability data in dose escalation and backfill module, through study completion, an average of 1 year.
RP2D as administered once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.
heart rate
Time frame: through study completion, an average of 1 year
electrocardiogram (ECG) QT Interval
Time frame: through study completion, an average of 1 year
17 secondary outcomes
Best overall response (BOR)
Time frame: through study completion, an average of 1 year
Overall response rate (ORR)
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
Maximum observed serum concentration (Cmax)
Time frame: through study completion, an average of 1 year
Anti-drug antibody (ADA)
Time frame: through study completion, an average of 1 year
Time to reach Cmax (Tmax)
Time frame: through study completion, an average of 1 year
Area under concentration-time profiles from zero to last timepoint of measurable concentration (AUClast)
Time frame: through study completion, an average of 1 year
Area under concentration-time profiles during a dose interval (AUCtau)
Time frame: through study completion, an average of 1 year
Terminal half-life (T1/2)
Time frame: through study completion, an average of 1 year
Steady state maximum concentration (Cmax, ss)
Time frame: through study completion, an average of 1 year
Steady state minimum concentration (Cmin, ss)
Time frame: through study completion, an average of 1 year
Clearance at steady state (CLss)
Time frame: through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
Time frame: through study completion, an average of 1 year
Ratio of AUC (Rac,AUC)
Time frame: through study completion, an average of 1 year
Ratio of Cmax (Rac,Cmax)
Time frame: through study completion, an average of 1 year
Degree of fluctuation (DF)
Time frame: through study completion, an average of 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 25 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T320 for Injection in people with Advanced Solid Tumor (Phase 1), run by Nanolattix Biotechnology Co., Ltd..
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 10 inclusion and 31 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: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 hua hua hao (15034114930, 1042918290@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Q2W: Up to 28 days). The study lists 7 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 25 Feb 2026.