A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors

NCT07181473 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TJ101-I-001
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 7

Brief 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. 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

Conditions

Lung Cancer (NSCLC); Prostate Cancer; Esophageal Cancer; Solid Tumor Malignancies

Keywords

TJ101; EGFR/B7-H3; phase 1; Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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.

  21 Days

• Number of participants with Serious Adverse Events (SAEs)

  Measuring the number of patients with Serious Adverse Events (SAEs)

  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

  2 years

• Number of participants with treatment-related adverse events (TRAEs)

  Measuring the number of patients with treatment-related TEAEs

  2 years

Secondary Outcomes (16)

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Duration of response (DoR)

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

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.

Drug: TJ101

Interventions

TJ101 DRUG

TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.

TJ101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Phrontline Biopharma: lead

Study Sites (7)

Florida Cancer Specialists & Research Institute

Orlando, Florida, 32827, United States

RECRUITING

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

RECRUITING

Oncology Consultants

Houston, Texas, 77030, United States

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Union Hospital of Tongji Medical College

Wuhan, Hubei, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Martin S Olivo, MD

CONTACT

551-427-2578; martin.olivo@phrontlinebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 18, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4); US (3)